Diabetes Mellitus, Type 2NCT03807440
DIA_CENTRAL:T2D Treatment Pattern in Central Europe
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 177 sites in 5 countries.
Trial summary
This is a non-interventional study using existing data including medical chart review. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin, Sodium Glucose Transporter 2 inhibitor and Dipeptidyl-peptidase 4 inhibitor
- How many people
- 4,083 participants
- Where
- 177 sitesin 5 countries
- Study dates
- 26 Aug 2019to 31 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18 years of age or older) with Type 2 Diabetes diagnosis, naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), DPP4i (Dipeptidyl-peptidase 4 inhibitor) or GLP1a (Glucagon-like peptide 1 agonist) at index date were chosen.
Who may be able to join
- Written informed consent prior to participation
- Female and male patients age ≥ 18 years
- Patients with T2D diagnosis
- Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)
- Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1
Who cannot join
- Patients age < 18 years
- Patients with diagnosis of other types of diabetes than T2D
- Patients who do not provide written consent to the terms of the study
Trial locations and contacts
177 sites in 5 countries.
177 sites in 5 countries
Russia66 sites
Anturium, Center Nr.: 70036
Barnaul, 656043
Central city hospital, Center Nr.: 70073
Bataysk, 346880
Chelyabinsk regional clinical hospital, Center Nr.: 70069
Chelyabinsk, 454076
Russian Medical Academy of Continuing Professional Education, Center Nr.: 70058
Irkutsk, 664049
The First Republican Clinical Hospital of the Ministry of Health of the Udmurt Republic, Center Nr.: 70037
Izhevsk, 426039
Central City Hospital No. 18, Center Nr.: 70051
Kazan', 420073
Kemerovo regional clinical hospital named S.V. Belyaev, Center Nr.: 70008
Kemerovo, 50066
City Polyclinic No. 16, Center Nr.: 70067
Khabarovsk, 680045
Kirov Clinical Hospital No. 7 named after V.I. Yurlova, Center Nr.: 70089
Kirov, 610020
Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo, Center Nr.: 70049
Krasnodar, 350086
Lipetsk Regional Hospital, Center Nr.: 70046
Lipetsk, 398902
SBIH Center for Speech Pathology and Neurorehabilitation MDH, Center Nr.: 70080
Moscow, 109240
Clinical Hospital No. 85 of trhe Federal Biomedical Agency, Center Nr.: 70042
Moscow, 115409
National Medical Research Center for Endocrinology, Center Nr.: 70025
Moscow, 117036
City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70043
Moscow, 117218
City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70045
Moscow, 117218
Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70032
Moscow, 119034
Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70041
Moscow, 119034
Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70081
Moscow, 119034
Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70084
Moscow, 119034
Vessel Clinic, Center Nr.: 70011
Moscow, 125252
City Polyclinic No 107 of the Moscow City Healthcare Department, Center Nr.: 70082
Moscow, 127273
City Clinical Hospital named after V.V. Veresaeva of the Moscow Department of Health, Center Nr.: 70003
Moscow, 127644
City Polyclinic No. 1, Center Nr.: 70074
Nal'chik, 360051
City clinical hospital #12 of Sormovskiy district of Nizhniy Novgorod, Center Nr.: 70018
Nizhny Novgorod, 603003
Privolzhsky Research Medical University, Center Nr.: 70085
Nizhny Novgorod, 603005
Novokuznetsk City Clinical Hospital No. 1, Center Nr.: 70050
Novokuznetsk, 654027
AVICENNA, Center Nr.: 70065
Novosibirsk, 630007
City Clinical Polyclinic #16, Center Nr.: 70056
Novosibirsk, 630078
Novosibirsk State Medical University, Center Nr.: 70059
Novosibirsk, 6300911
AVICENNA, Center Nr.: 70064
Novosibirsk, 630099
Penza regional clinical hospital named after N.N. Burdenko, Center Nr.: 70095
Penza, 440026
Private Clinic Salon Roden, Center Nr.: 70086
Perm, 614000
City clinical hospital 5, Center Nr.: 70057
Perm, 614010
City clinical hospital 5, Center Nr.: 70070
Perm, 614010
City polyclinic #16 of the City Rostov-on-Don, Center Nr.: 70027
Rostov-on-Don, 344092
North-West State Medical University named after II. Mechnikov, Center Nr.: 70053
Saint Petersbug, 191015
North-West State Medical University named after II. Mechnikov, Center Nr.: 70077
Saint Petersbug, 191015
First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70024
Saint Petersburg, 197022
First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70087
Saint Petersburg, 197022
Medilux-TM, Center Nr.: 70005
Saint Petersburg, 197227
V.A. Almazov National Medical Research Center, Center Nr.: 70071
Saint Petersburg, 197341
AntMed, Center Nr.: 70034
Saint Petersburg, 197349
Dr. Tsiberkin, Center Nr.: 70048
Saint Petersburg, 197349
City Pokrovskaya Hospital, Center Nr.: 70022
Saint Petersburg, 199106
Zabotlivyi Doktor, Center Nr.: 70016
Saint Petersburg, 966550
Samara city polyclinic Nr. 9 of Oktyabrskiy district, Center Nr.: 70028
Samara, 443110
Samara city consulting and diagnostic polyclinic nr. 14, Center Nr.: 70029
Samara, 443111
Clinical Hospital of the Saratov city, Center Nr.: 70090
Saratov, 410004
LLC clinic "Family Doctor", Center Nr.: 70093
Saratov, 410012
Multifunctional Medical Clinic "Sova", Center Nr.: 70030
Saratov, 410056
Regional Endocrinological Dispensary, Center Nr.: 70078
Stavropol, 355045
Tyumen State Medical University, Center Nr.: 70066
Tyumen, 625023
City clinical hospital, Center Nr.: 70019
Ufa, 450014
City Polyclinic No.2, Center Nr.: 70062
Ulan-Ude, 670031
Limited Liability Company "CENTER", Center Nr.: 70060
Vladivostok, 690017
Regional Clinical Hospital No. 2, Center Nr.: 70092
Vladivostok, 690035
Regional Clinical Hospital No. 2, Center Nr.: 70068
Vladivostok, 690105
Volgograd Regional Clinical Hospital No. 3, Center Nr.: 70076
Volgograd, 400001
Clinical Polyclinic No.28, Center Nr.: 70040
Volgograd, 400117
Voronezh City Clinical Hospital #11, Center Nr.: 70035
Voronezh, 394042
State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70017
Voronezh, 394077
State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70033
Voronezh, 394077
State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70055
Voronezh, 394077
Limited Liability Company "Uralsky Medical Center", Center Nr.: 70063
Yekaterinburg, 620102
Scientific and Practical Center of Specialized Types of Medical Care "Uralskij Institute of Cardiology", Center Nr.: 70079
Yekaterinburg, 620144
Czechia58 sites
Michal Brada, Center Nr.: 42001
Beclav, 69002
Dr. Kovaová, Center Nr.: 42069
Beroun, 26656
Practice Dr. Alice Sýkorová, Center Nr.: 42057
Bílina, 418 01
MUDr. Alica Vesela, Center Nr.: 42030
Broumov, 55001
EUC Klinika eské Budjovice, Center Nr.: 42052
Eské Budjovice, 37001
Lékaský dm Géko, Center Nr.: 42059
Eské Budjovice, 37011
Barbara Buzová, Center Nr.: 42003
Havíov, 73601
Zaviatiová, Petra, Center Nr.: 42004
Havíov, 73601
Radana Syslová, Center Nr.: 42035
Hlušovice, 78314
Pavel Kasík, Center Nr.: 42046
Hoovice, 268 31
Practice Dr. Petr Maule, Center Nr.: 42054
Humpolec, 39601
Mediab Jihlava s.r.o., Center Nr.: 42066
Jihlava, 58601
Practice MUDr. Gita Markofová, Center Nr.: 42053
Karlovy Vary, 36066
Dr. Konená, Center Nr.: 42036
Karviná - Staré Msto, 73301
Practice Zdzislaw Wranka, Center Nr.: 42072
Karviná-Hranice, 73301
Pavel Tománek, Center Nr.: 42028
Kopivnice, 74221
DIABET HELP s.r.o., Center Nr.: 42058
Kralupy nad Vltavou, 27801
MUDr.Tomáš Edelsberger, Center Nr.: 42007
Krnov, 79401
Jitka Hasalová, Center Nr.: 42010
Kromiz, 76901
árka Drinková, Center Nr.: 42038
Lede Nad Sázavou, 58401
Martina Košková, Center Nr.: 42047
Mladá Boleslav, 29350
Dobromila Vykoupilová, Center Nr.: 42033
Nmice Nad Hanou, 79827
Karel Churavý, Center Nr.: 42005
Nový Jiín, 74101
árka Kubánková, Center Nr.: 42048
Nymburk, 28802
Agentura Science Pro spol. s.r.o., Center Nr.: 42002
Olomouc, 772 00
Anna Rancová, Center Nr.: 42025
Olomouc, 77900
Josef íný, Center Nr.: 42026
Opava, 74601
MUDr.Tomáš Hrdina, Center Nr.: 42015
Opono, 51773
Dr. Šeptáková, Center Nr.: 42074
Ostrava, 700 30
Practice Dr. René Turínek, Center Nr.: 42034
Ostrava, 70200
MUDr. Eva Raická, Center Nr.: 42024
Ostrava, 71000
Jitka Homolová, Center Nr.: 42012
Ostrava, 72880
Radka Nágelová, Center Nr.: 42020
Ostrava Poruba, 70800
AIDIN VK s.r.o., Center Nr.: 42017
Perov, 75301
MUDr. Vra Prýmková, Center Nr.: 42070
Píbram, 26101
Zdenk Jankovec, Center Nr.: 42044
Plze, 30100
Diabetologická a interní ambulance, Center Nr.: 42064
Podbrady, 29001
MUDr. Jana Houdová, Center Nr.: 42068
Prague, 10000
Practice Dr. Milena Peterková, Center Nr.: 42063
Prague, 12143
MUDr.Michala Pelikánová s.r.o., Center Nr.: 42055
Prague, 14000
Markéta Hovorková, Center Nr.: 42042
Prague, 14021
Jakub Hron, Center Nr.: 42043
Prague, 14300
Milan Fleka, Center Nr.: 42041
Prague, 15000
Jií Jón, Center Nr.: 42045
Prague, 15030
Practice Dr. Lucie Kufová, Center Nr.: 42062
Prague, 15030
Practice Dr. Ida Reissová, Center Nr.: 42056
Prague, 16300
Barbora Diepoltová, Center Nr.: 42037
Prague, 19014
Practice Dr. Petronela Janeková, Center Nr.: 42065
Rumburk, 40801
Practice Dr. Miroslav Lindovský, Center Nr.: 42051
Sokolov, 35601
Dana Fialkoviová, Center Nr.: 42040
Strakonice, 38601
Marek Frydrych, Center Nr.: 42008
Tebí, 674 01
Marek Frydrych, Center Nr.: 42077
Tebí, 674 01
Diabetologická ambulance s.r.o., Center Nr.: 42076
Uherské Hradišt, 68601
Dr. Hrmová, Center Nr.: 42073
Vlašim, 25801
Lubomír Kudlej, Center Nr.: 42050
Vrchlabí, 54301
AdiaMed s.r.o., Center Nr.: 42009
Vsetín, 75501
EUC Klinika Zlín a.s., Center Nr.: 42075
Zlín, 76001
Robin Urbánek, Center Nr.: 42029
Zlín, 76001
Poland28 sites
Gabinet Diabetologiczno- Internistyczny Katarzyna Wasilewska, Center Nr.: 48011
Biaystok, 15-591
NZOZ DIAMED Sp. z o.o., Center Nr.: 48061
Czechowice-Dziedzice, 43-502
Prywatny Gabinet Lekarski dr n. med. Joanna Sawer-Szewczyk, Center Nr.: 48055
Czyca, 99-100
Zespó Opieki Zdrowotnej w czycy, Center Nr.: 48054
Czyca, 99-100
NZOZ Sal Med, Center Nr.: 48047
Dzieroniów, 58-200
Poradnia Diabetologiczna, Center Nr.: 48028
Gorlice, 38-300
Indywidualna Specjalistyczna Praktyka Lekarska Piotr Piskozub Specjalista Diabetolog, Center Nr.: 48042
Jelenia Góra, 58-506
NZOZ Poradnia Diabetologiczna, Center Nr.: 48038
Konin, 62-504
Zakad Opieki Medycznej Sanatio; Sp. Z. o.o., Center Nr.: 48030
Krakow, 31-548
Prywatny Gabinet Lekarski Tomasz Wierzykowski, Center Nr.: 48053
Kutno, 99-300
Indywidualna Specjalistyczna Praktyka Lekarska Magorzata Poskoska-Lemaska, Center Nr.: 48035
Kwidzyn, 82-500
Indywidualna Specjalistyczna Praktyka Lekarska Barbara Soróbka, Center Nr.: 48001
Legnica, 59-220
Poradnia Cukrzycowa SP ZOZ w Lesku, Center Nr.: 48024
Lesko, 38-600
Lumed Sp. z o.o., Center Nr.: 48032
Lubaczów, 37-600
DIABETA-CARE Sp.z o.o., Center Nr.: 48008
Lubin, 59-300
Poradnia Diabetologiczna Dr. mudziska, Center Nr.: 48013
Nako Nad Noteci, 89-100
Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Center Nr.: 48007
Nowy Scz, 33-300
Poradnia Diabetologiczna Dr. Adamczyk-Gajda, Center Nr.: 48031
Olenica, 56-400
MED-ART Sp. z o.o., Center Nr.: 48052
Orzesze, 43-180
Indywidualna Specjalistyczna Praktyka Lekarska Wiesawa Fischer, Center Nr.: 48020
Ostrów Wielkopolski, 63-400
Prywatny Gabinet Lekarski azuka, Center Nr.: 48026
Parczew, 21-200
Powiatowy Szpital Specjalistyczny w Stalowej Woli, Center Nr.: 48056
Stalowa Wola, 37-450
Prywatny Gabinet Lekarski dr n. med. Piotr Gryglas, Center Nr.: 48059
Warsaw, 03-922
Poradnia Diabetologiczna Szpitala Powiatowego w Wicborku, Center Nr.: 48003
Wicbork, 89-410
Orodek Praktyka Lekarska Konrad Strzelczyk, Center Nr.: 48012
Woomin, 05-200
Poradnia Diabetologiczna SPZZOZ w Wyszkowie, Center Nr.: 48067
Wyszków, 07-200
Wojewódzka Poradnia dla Chorych na Cukrzyc, Center Nr.: 48025
Zabrze, 41-800
Cardiomed, Center Nr.: 48019
Zielona Góra, 65-001
Bulgaria15 sites
MHAT "Julia Verevska-Byala" EOOD, Center Nr.: 35903
Byala, 7100
MC "Diamedical 2013" OOD, Center Nr.: 35902
Dimitrovgrad, 6400
MBAL- Dobrich AD, Center Nr.: 35916
Dobrich, 9300
Dr. T. K. Bacheva - ASMP-IP-E EOOD, Center Nr.: 35904
Dupnitsa, 2600
MHAT "Medline Clinic", Center Nr.: 35911
Plovdiv, 4000
MC Kuchuk Parij OOD, Center Nr.: 35906
Plovdiv, 4030
MC Saint Elisaveta-Rakovski EOOD, Center Nr.: 35909
Rakovski, 4150
"Medical Center-Razgrad"OOD, Center Nr.: 35910
Razgrad, 7200
DCC 1 - Russe EOOD, Center Nr.: 35905
Rousse, 7000
MBAL "Hadzhi Dimitar" OOD, Center Nr.: 35915
Sliven, 8800
MC Polimed AD, Center Nr.: 35907
Sofia, 1303
MC Gina - LZ SIMP EOOD, Center Nr.: 35918
Sofia, 1463
MC "Vitaclinic" EOOD, Center Nr.: 35901
Sofia, 1680
MC Kalimat EOOD, Center Nr.: 35914
Sofia, 1680
Acibadem City Clinic Medical Center Varna EOOD, Center Nr.: 35908
Varna, 9002
Hungary10 sites
Bajcsy-Zsilinszky Kórház és Rendelintézet, Center Nr.: 36019
Budapest, 1106
Jahn Ferenc Dél-pesti Kórház és Rendelintézet, Center Nr.: 36014
Budapest, 1204
Debreceni Egyetem Klinikai Központ, Kardiológiai Klinika, Center Nr.: 36006
Debrecen, 4032
Kátai Gábor Kórház, Diabetológia Szakrendelés, Center Nr.: 36007
Karcag, 5300
Practice Dr. Lelkesi Anita, Center Nr.: 36013
Mátészalka, 4700
Nagyatádi Kórház, Center Nr.: 36021
Nagyatád, 7500
Nyírségi Diabetes Centrum, Center Nr.: 36024
Nyíregyháza, 4400
Dr. Wagner Zoltán, Center Nr.: 36020
Pécs, 7625
Siófoki Kórház Rendelintézet, Center Nr.: 36004
Siófok, 8600
Soproni Gyógyközpont, Center Nr.: 36018
Sopron, 9400
About this study
Official title: CORDIALLY® - CEE: Characteristics of Patients With Type 2 Diabetes Treated With Modern Antidiabetic Drugs. A Real World Data Collection of Patient Baseline Characteristics, Treatment Patterns and Comorbidities in Central Eastern European (CEE) Countries
This is a non-interventional study using existing data including medical chart review.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin, Sodium Glucose Transporter 2 inhibitor, Dipeptidyl-peptidase 4 inhibitor, Glucagon-like peptide 1 agonist
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance® Synjardy® Trajenta® Jentadueto®
Empagliflozin
Sodium Glucose Transporter 2 inhibitorDrug
Also called Jardiance® Synjardy® Trajenta® Jentadueto®
Sodium Glucose Transporter 2 inhibitor
Dipeptidyl-peptidase 4 inhibitorDrug
Also called Jardiance® Synjardy® Trajenta® Jentadueto®
Dipeptidyl-peptidase 4 inhibitor
Glucagon-like peptide 1 agonistDrug
Also called Jardiance® Synjardy® Trajenta® Jentadueto®
Glucagon-like peptide 1 agonist
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Diabetes Mellitus, Type 2 | Not described Receives: Drug: Empagliflozin; Drug: Sodium Glucose Transporter 2 inhibitor; Drug: Dipeptidyl-peptidase 4 inhibitor; Drug: Glucagon-like peptide 1 agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist
Number of patients in each category of prescription of a respective modern Type 2 Diabetes (T2D) medication according to prescribing specialist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant T2D Medications at Study Index Date 1 According to Prescribing Specialist
Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant T2D medications at study index date 1 according to prescribing specialist is reported.
The concomitant T2D medications reported are:
- Metformin
- Sulfonylurea
- Acarbose
- Pioglitazone
- Insulin
- Others
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant Cardiovascular Disease (CVD) and/or Chronic Kidney Disease (CKD) Medication at Study Index Date 1 According to Prescribing Specialist
Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant cardiovascular disease (CVD) and/or chronic kidney disease (CKD) medication at study index date 1 according to prescribing specialist is reported.
The reported concomitant CVD and/or chronic CKD medications are:
- Antihypertensive angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs)
- Statins
- Low dose aspirin
- Beta blockers
- Diuretics
- Others
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The reported categories of gender are:
- Female
- Male
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The reported categories of race are:
- Black
- Non-black
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The reported categories of gender are:
- Female
- Male
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The reported categories of race are:
- Black
- Non-black
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The reported categories of gender are:
- Female
- Male
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The reported categories of race are:
- Black
- Non-black
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Clinical parameter relevant for Type 2 Diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for T2D: Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Clinical parameter relevant for Type 2 Diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The reported categories of percentage (%) of glycosylated hemoglobin are:
- <8.5%
- ≥8.5%
- Missing
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
The reported categories of percentage of glycosylated hemoglobin are:
- <8.5%
- ≥8.5%
- Missing
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
The reported categories of percentage of glycosylated hemoglobin are:
- <8.5%
- ≥8.5%
- Missing
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Secondary outcomes (40)
Number of Patients With Any Type of Cardiovascular Disease (CVD)
Number of patients with cardiovascular disease (CVD) is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by Physician's Assessment
Number of patients with chronic kidney disease (CKD) by physician's assessment (patients for whom CKD was reported as a comorbidity) is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Documentation of Estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) Status
Number of patients with documentation of estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) status is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by Estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) Status
Number of patients with Chronic Kidney Disease (CKD) by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of the Different Types of Cardiovascular Disease
Number of patients in each category of the different types of cardiovascular disease is reported.
The following types of cardiovascular diseases are reported:
- Myocardial infarction
- Cardiology intervention (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG))
- Ischemic heart disease
- Congestive heart failure
- Stroke
- Peripheral arterial disease
The categories reported for each type of cardiovascular disease are:
- Yes
- No
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of the Different Types of Congestive Heart Failure (CHF) - Confirmed by Echocardiography
Number of patients in each category of the different types of congestive heart failure (CHF) which was confirmed by echocardiography is reported.
The reported categories of congestive heart failure confirmed by echocardiography are:
- Yes
- No
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Any Type of Cardiovascular Disease (CVD) and Without CVD According to Prescribing Specialist
Number of patients with any type of cardiovascular disease (CVD) or without CVD according to prescribing specialist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) (Patients for Whom CKD Was Reported as a Comorbidity) or Without CKD by Physician's Assessment According to Prescribing Specialist
Number of patients with chronic kidney (CKD) and without CKD by physician's assessment according to prescribing specialist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by eGFR and UACR Status According to Prescribing Specialist
Number of patients with chronic kidney disease (CKD) by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status - according to prescribing specialist is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Different Types of Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of different types of cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The following types of cardiovascular diseases are reported:
- Myocardial infarction
- Cardiology intervention (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG))
- Ischemic heart disease
- Congestive heart failure
- Stroke
- Peripheral arterial disease
The categories reported for each type of cardiovascular disease are:
- Yes
- No
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Congestive Heart Failure (CHF) Confirmed by Echocardiography According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of congestive heart failure (CHF) confirmed by echocardiography according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication From by Endocrinologist
Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) or Without CKD by Physician's Assessment According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients with chronic kidney (CKD) (patients for whom CKD was reported as a comorbidity) or without CKD by physician's assessment according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) and Without CKD by eGFR and UACR Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients with chronic kidney (CKD) (patients for whom CKD was reported as a comorbidity) and without CKD by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of family status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
Measured: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication by Country
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication by country is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients for Each Type of Physician Specialties Involved in Decision for T2D Therapy Discontinuation According to Prescribing Specialist
Number of patients for each type of physician specialties involved in decision for T2D therapy discontinuation according to prescribing specialist is reported.
Measured: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Time to Discontinuation of Type 2 Diabetes (T2D) Treatment According to Study Medication
Time to discontinuation of type 2 diabetes (T2D) treatment according to study medication is reported.
Time to discontinuation of T2D medication was estimated by Kaplan-Meier analysis. Patients who did not discontinue study medication at study index date 2 were censored.
Measured: From date of first prescription (study index date 1) to stop date of initial type 2 diabetes (T2D)) medication (documented at index date 2), up to 14 months..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start26 Aug 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,083 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Medvedchikov, +43180105-7896, Study chair, Alexey.Medvedchikov@Boehringer-Ingelheim.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807440
- Sponsor's protocol ID
- 1245-0187
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2019
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Publications
Prazny M, Suplotova L, Gumprecht J, Kamenov Z, Fulop T, Medvedchikov A, Rosenzweig D, Aleksandric M. Real-world characteristics, modern antidiabetic treatment patterns, and comorbidities of patients with type 2 diabetes in central and Eastern Europe: retrospective cross-sectional and longitudinal evaluations in the CORDIALLY(R) study. Cardiovasc Diabetol. 2022 Oct 8;21(1):203. doi: 10.1186/s12933-022-01631-4.
PubMed 36209118
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORDIALLY® - CEE: Characteristics of Patients With Type 2 Diabetes Treated With Modern Antidiabetic Drugs. A Real World Data Collection of Patient Baseline Characteristics, Treatment Patterns and Comorbidities in Central Eastern European (CEE) Countries
- ClinicalTrials.gov ID
- NCT03807440
- Acronym / sponsor ID
- 1245-0187
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,083 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional study using existing data including medical chart review.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Diabetes Mellitus, Type 2 | – | Drug: Empagliflozin, Drug: Sodium Glucose Transporter 2 inhibitor, Drug: Dipeptidyl-peptidase 4 inhibitor, Drug: Glucagon-like peptide 1 agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years of age or older) with Type 2 Diabetes diagnosis, naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), DPP4i (Dipeptidyl-peptidase 4 inhibitor) or GLP1a (Glucagon-like peptide 1 agonist) at index date were chosen.
Key inclusion criteria (5 listed)
- Written informed consent prior to participation
- Female and male patients age ≥ 18 years
- Patients with T2D diagnosis
- Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)
- Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1
Key exclusion criteria (3 listed)
- Patients age < 18 years
- Patients with diagnosis of other types of diabetes than T2D
- Patients who do not provide written consent to the terms of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: Jardiance® Synjardy® Trajenta® Jentadueto®Empagliflozin | Drug | Subjects with Diabetes Mellitus, Type 2 |
| Sodium Glucose Transporter 2 inhibitorAlso: Jardiance® Synjardy® Trajenta® Jentadueto®Sodium Glucose Transporter 2 inhibitor | Drug | Subjects with Diabetes Mellitus, Type 2 |
| Dipeptidyl-peptidase 4 inhibitorAlso: Jardiance® Synjardy® Trajenta® Jentadueto®Dipeptidyl-peptidase 4 inhibitor | Drug | Subjects with Diabetes Mellitus, Type 2 |
| Glucagon-like peptide 1 agonistAlso: Jardiance® Synjardy® Trajenta® Jentadueto®Glucagon-like peptide 1 agonist | Drug | Subjects with Diabetes Mellitus, Type 2 |
Primary outcome
Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients in each category of prescription of a respective modern Type 2 Diabetes (T2D) medication according to prescribing specialist is reported.
Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant T2D Medications at Study Index Date 1 According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant T2D medications at study index date 1 according to prescribing specialist is reported. The concomitant T2D medications reported are: * Metformin * Sulfonylurea * Acarbose * Pioglitazone * Insulin * Others
Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant Cardiovascular Disease (CVD) and/or Chronic Kidney Disease (CKD) Medication at Study Index Date 1 According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant cardiovascular disease (CVD) and/or chronic kidney disease (CKD) medication at study index date 1 according to prescribing specialist is reported. The reported concomitant CVD and/or chronic CKD medications are: * Antihypertensive angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs) * Statins * Low dose aspirin * Beta blockers * Diuretics * Others
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of gender are: * Female * Male
Baseline Characteristic: Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of race are: * Black * Non-black
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of gender are: * Female * Male
Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of race are: * Black * Non-black
Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.
Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of gender are: * Female * Male
Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter^2 (kg/m^2)).
Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of race are: * Black * Non-black
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for Type 2 Diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Clinical Parameter Relevant for T2D: Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for Type 2 Diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of percentage (%) of glycosylated hemoglobin are: * <8.5% * ≥8.5% * Missing
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of percentage of glycosylated hemoglobin are: * <8.5% * ≥8.5% * Missing
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c [%]) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of percentage of glycosylated hemoglobin are: * <8.5% * ≥8.5% * Missing
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
40 secondary outcomes
Number of Patients With Any Type of Cardiovascular Disease (CVD)
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by Physician's Assessment
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Documentation of Estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) Status
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by Estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) Status
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of the Different Types of Cardiovascular Disease
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of the Different Types of Congestive Heart Failure (CHF) - Confirmed by Echocardiography
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Any Type of Cardiovascular Disease (CVD) and Without CVD According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) (Patients for Whom CKD Was Reported as a Comorbidity) or Without CKD by Physician's Assessment According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney Disease (CKD) by eGFR and UACR Status According to Prescribing Specialist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Different Types of Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Congestive Heart Failure (CHF) Confirmed by Echocardiography According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication From by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) or Without CKD by Physician's Assessment According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients With Chronic Kidney (CKD) and Without CKD by eGFR and UACR Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 1 (i.e. between September 2018 and December 2018).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication by Country
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of Patients for Each Type of Physician Specialties Involved in Decision for T2D Therapy Discontinuation According to Prescribing Specialist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Time to Discontinuation of Type 2 Diabetes (T2D) Treatment According to Study Medication
Time frame: From date of first prescription (study index date 1) to stop date of initial type 2 diabetes (T2D)) medication (documented at index date 2), up to 14 months..
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36209118Prazny M, Suplotova L, Gumprecht J, Kamenov Z, Fulop T, Medvedchikov A, Rosenzweig D, Aleksandric M. Real-world characteristics, modern antidiabetic treatment patterns, and comorbidities of patients with type 2 diabetes in central and Eastern Europe: retrospective cross-sectional and longitudinal evaluations in the CORDIALLY(R) study. Cardiovasc Diabetol. 2022 Oct 8;21(1):203. doi: 10.1186/s12933-022-01631-4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Medvedchikov, +43180105-7896 study chair
Alexey.Medvedchikov@Boehringer-Ingelheim.com
177 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 177 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 177 sites in Russia, Czechia, Poland, Bulgaria, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist (time frame: At study index date 1 (i.e. between September 2018 and December 2018).). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.