Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity

An observational study of Type 2 Diabetes and Obesity, run by Ana Palanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Type 2 diabetes (T2D) is a progressive chronic condition associated with a high morbi-mortality that has a considerable impact on healthcare resources. Glucagon-like peptide-1 receptor agonists (GLP-1RA) are incretin mimetics that have been shown to improve glycemic control with a low associated risk of hypoglycemia. Read more about this study

Who is it for?: Ages 18 to 125 years
Conditions the study is for: Type 2 Diabetes, Obesity
What is being tested?: GLP-1RA, SGLT2i and Insulin
How many people: 26,944 participants
Where: 1 siteSpain
Study dates: 1 Jan 2014to 1 Sep 2022
Phase: Observational
Are there results?: None posted in the registry

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 to 125 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All identified adults with type 2 diabetes registered in the Population Information System (SIP) of the Valencian Community and corresponding to the Valencia Clínico-La Malvarrosa Health Department who were diagnosed before the end of the study period were included. Type 2 diabetes (T2D) diagnosis was defined according to the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes. To exclude temporary treatment effects due to short-term use of the antidiabetic treatments, only individuals in the study groups with at least a 6-month prescription were included in the analyses.

Who may be able to join

Adults with type 2 diabetes
Individuals with at least a 6-month prescription

Who cannot join

Individuals below 18
Individuals with less than a 6-month prescription

Trial locations and contacts

1 site in 1 country.

Spain1 site

INCLIVA
Valencia, 46010

Other trials in Spain

About this study

Official title: Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity in the Department of Health of Valencia Clínico-Malvarrosa

Type 2 diabetes (T2D) is a progressive chronic condition associated with a high morbi-mortality that has a considerable impact on healthcare resources.

Glucagon-like peptide-1 receptor agonists (GLP-1RA) are incretin mimetics that have been shown to improve glycemic control with a low associated risk of hypoglycemia. Additionally, previous studies have linked the use of GLP-1RA with a reduction in the risk of cardiovascular events and kidney disease progression. Despite these positive results, GLP1-RA´s prescription, following the failure of treatment with metformin monotherapy or dual therapy, remains low in Spain compared to other countries in our milieu. Furthermore, the use of this therapeutic class is not homogeneous across the different autonomous communities in Spain, and, no objective justification for these differences seems to exist. Consequently, there is a need to understand which are the benefits associated with the use of GLP-1RA, versus intensification with other oral agents, in real-life conditions.

In this study, the impact of the use of GLP-1RA on clinical outcomes such as all-cause mortality, cardiovascular and renal outcomes as well as severe hypoglycemia will be evaluated based on the analysis of longitudinal databases that collect the variables of interest generated in a real-life scenario. In addition, both persistence and adherence to treatment in patients treated with GLP-1RA and its impact on the clinical outcomes of interest will be studied. Finally, therapeutic inertia will be analyzed.

All these data will contribute to generating cost-effective strategies aimed at improving health outcomes among T2D patients in our setting, reinforcing persistence and adherence to the prescribed treatment, and reducing therapeutic inertia in this group of patients.

Since the use of GLP-1RA versus intensification with other oral agents has been associated with better glycemic control, and, when compared to intensification with basal insulin, with a lower incidence of severe hypoglycemia, we hypothesized that T2D adults treated with GLP-1RA would present a lower incidence of cardiovascular and renal outcomes and fewer hospitalizations due to severe hypoglycemia events as well as a decreased all-cause mortality. On the other hand, patients on GLP-1RA who would present greater persistence and adherence to treatment should experience fewer cardiovascular and renal outcomes and lower mortality compared to those with less persistence and adherence. Finally, it is possible that the type of GLP-1RA and the mode of administration, weekly versus daily, may influence adherence, persistence and therapeutic inertia in this group of patients.

Conditions: Type 2 Diabetes, Obesity
Being tested: GLP-1RA, SGLT2i, Insulin, Miscellany
Medical subject headings: Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLP-1RADrug
All T2D adults treated with Glucagon-like peptide-1 receptor agonists (GLP-1RA) or initiating a GLP-1RA during the study period
SGLT2iDrug
SGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with Sodium/glucose cotransporter-2 inhibitors (SGLT2i) or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA
InsulinDrug
Insulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i
MiscellanyDrug
Other glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period and who were treated with other glucose-lowering agents during the study period

Study groups in NCT05535322
Study group	Role	What they receive
GLP-1RA		All GLP-1RA users: all T2D adults treated with GLP-1RA or initiating a GLP-1RA during the study period Receives: Drug: GLP-1RA
SGLT2i		SGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with SGLT2i or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA Receives: Drug: SGLT2i
Insulin		Insulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i Receives: Drug: Insulin
Miscellany		Other glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period. Receives: Drug: Miscellany

What is being measured

The primary outcome is the main question the study is designed to answer.

Major acute cardiovascular events
In this work, this composite includes patients suffering from non-fatal acute myocardial infarction (AMI) and non-fatal stroke, transient ischemic attack (TIA), all-cause death, and, heart failure events occurring during the study period (from inclusion in the study until the event or the end of the study period, whichever came first).
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.

Secondary outcomes (11)

Major acute cardiovascular events without heart failure
In this work, this composite includes patients suffering from non-fatal acute myocardial infarction (AMI) and non-fatal stroke, transient ischemic attack (TIA) and all-cause death occurring during the study period (from inclusion in the study until the event or the end of the study period, whichever came first).
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
AMI
Acute myocardial infarction events occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Stroke
Stroke events occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Heart Failure
Heart failure hospitalization occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: Through study completion (from inclusion in the study until the event or the end of the study period, whichever came first)
all-cause death
Death from all causes occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Renal progression
Sustained 40% reduction in eGFR occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
atrial fibrillation
Events of atrial fibrillation episodes occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Hypoglycemia
Severe hypoglycemia requiring hospitalization occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Measured: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Persistence
Persistence on treatment was defined as the percentage of patients continuing treatment from the start of the study period or since the first prescription during the study period until evidence of discontinuation or the end of the study period.
Measured: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Adherence
Treatment adherence was defined as the proportion of days covered (days in which an individual had access to the medication) from the start of the study period or since the first prescription during the study period until treatment discontinuation
Measured: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Therapeutic inertia
Therapeutic inertia was defined as non-intensification of treatment once started despite HbA1c ≥7.5% during follow-up.
Measured: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20141 Sep 2022

First posted10 Sep 2022
Study start1 Jan 2014
Primary completion31 Dec 2019
Study completion1 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
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: Cohort
Time perspective: Retrospective
Enrolment: 26,944 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05535322
Sponsor's protocol ID: GLP-1RA in T2D
Status last verified: Sep 2022
First submitted: 7 Mar 2022
Last updated: 28 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Blonde L, Raccah D, Lew E, Meyers J, Nikonova E, Ajmera M, Davis KL, Bertolini M, Guerci B. Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin. Diabetes Ther. 2018 Jun;9(3):1169-1184. doi: 10.1007/s13300-018-0429-x. Epub 2018 Apr 19.
PubMed 29675797
Carls GS, Tuttle E, Tan RD, Huynh J, Yee J, Edelman SV, Polonsky WH. Understanding the Gap Between Efficacy in Randomized Controlled Trials and Effectiveness in Real-World Use of GLP-1 RA and DPP-4 Therapies in Patients With Type 2 Diabetes. Diabetes Care. 2017 Nov;40(11):1469-1478. doi: 10.2337/dc16-2725. Epub 2017 Aug 11.
PubMed 28801475
Chatterjee S, Davies MJ, Khunti K. What have we learnt from "real world" data, observational studies and meta-analyses. Diabetes Obes Metab. 2018 Feb;20 Suppl 1:47-58. doi: 10.1111/dom.13178.
PubMed 29364585
Conget I, Mauricio D, Ortega R, Detournay B; CHADIG Study investigators. Characteristics of patients with type 2 diabetes mellitus newly treated with GLP-1 receptor agonists (CHADIG Study): a cross-sectional multicentre study in Spain. BMJ Open. 2016 Jul 26;6(7):e010197. doi: 10.1136/bmjopen-2015-010197.
PubMed 27466235
Divino V, Boye KS, Lebrec J, DeKoven M, Norrbacka K. GLP-1 RA Treatment and Dosing Patterns Among Type 2 Diabetes Patients in Six Countries: A Retrospective Analysis of Pharmacy Claims Data. Diabetes Ther. 2019 Jun;10(3):1067-1088. doi: 10.1007/s13300-019-0615-5. Epub 2019 Apr 26.
PubMed 31028689
Divino V, DeKoven M, Khan FA, Boye KS, Sapin H, Norrbacka K. GLP-1 RA Treatment Patterns Among Type 2 Diabetes Patients in Five European Countries. Diabetes Ther. 2017 Feb;8(1):115-128. doi: 10.1007/s13300-016-0224-5. Epub 2017 Jan 9.
PubMed 28070733
Fadini GP, Frison V, Rigato M, Morieri ML, Simioni N, Tadiotto F, D'Ambrosio M, Paccagnella A, Lapolla A, Avogaro A. Trend 2010-2018 in the clinical use of GLP-1 receptor agonists for the treatment of type 2 diabetes in routine clinical practice: an observational study from Northeast Italy. Acta Diabetol. 2020 Mar;57(3):367-375. doi: 10.1007/s00592-019-01445-z. Epub 2019 Oct 31.
PubMed 31673896
Fu AZ, Qiu Y, Davies MJ, Radican L, Engel SS. Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes Obes Metab. 2011 Aug;13(8):765-9. doi: 10.1111/j.1463-1326.2011.01405.x.
PubMed 21457427
Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.
PubMed 27531506
Guerci B, Charbonnel B, Gourdy P, Hadjadj S, Hanaire H, Marre M, Verges B. Efficacy and adherence of glucagon-like peptide-1 receptor agonist treatment in patients with type 2 diabetes mellitus in real-life settings. Diabetes Metab. 2019 Dec;45(6):528-535. doi: 10.1016/j.diabet.2019.01.006. Epub 2019 Jan 21.
PubMed 30677504
Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.
PubMed 30291013
Kristensen SL, Rorth R, Jhund PS, Docherty KF, Sattar N, Preiss D, Kober L, Petrie MC, McMurray JJV. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet Diabetes Endocrinol. 2019 Oct;7(10):776-785. doi: 10.1016/S2213-8587(19)30249-9. Epub 2019 Aug 14.
PubMed 31422062
Lin J, Lingohr-Smith M, Fan T. Real-world medication persistence and outcomes associated with basal insulin and glucagon-like peptide 1 receptor agonist free-dose combination therapy in patients with type 2 diabetes in the US. Clinicoecon Outcomes Res. 2016 Dec 22;9:19-29. doi: 10.2147/CEOR.S117200. eCollection 2017.
PubMed 28053550
Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.
PubMed 32372454
Khunti K, Gomes MB, Pocock S, Shestakova MV, Pintat S, Fenici P, Hammar N, Medina J. Therapeutic inertia in the treatment of hyperglycaemia in patients with type 2 diabetes: A systematic review. Diabetes Obes Metab. 2018 Feb;20(2):427-437. doi: 10.1111/dom.13088. Epub 2017 Oct 1.
PubMed 28834075

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity in the Department of Health of Valencia Clínico-Malvarrosa
ClinicalTrials.gov ID: NCT05535322
Acronym / sponsor ID: GLP-1RA in T2D
Conditions: Type 2 Diabetes, Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 26,944 participants (actual)
Lead sponsor: Ana PalancaUniversity, hospital or other
Study start: 1 Jan 2014 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 10 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Type 2 diabetes (T2D) is a progressive chronic condition associated with a high morbi-mortality that has a considerable impact on healthcare resources.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
GLP-1RA	–	Drug: GLP-1RAAll GLP-1RA users: all T2D adults treated with GLP-1RA or initiating a GLP-1RA during the study period
SGLT2i	–	Drug: SGLT2iSGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with SGLT2i or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA
Insulin	–	Drug: InsulinInsulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i
Miscellany	–	Drug: MiscellanyOther glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period.

Who may qualify

Ages: 18 to 125 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All identified adults with type 2 diabetes registered in the Population Information System (SIP) of the Valencian Community and corresponding to the Valencia Clínico-La Malvarrosa Health Department who were diagnosed before the end of the study period were included. Type 2 diabetes (T2D) diagnosis was defined according to the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes. To exclude temporary treatment effects due to short-term use of the antidiabetic treatments, only individuals in the study groups with at least a 6-month prescription were included in the analyses.

Key inclusion criteria (2 listed)

Adults with type 2 diabetes
Individuals with at least a 6-month prescription

Key exclusion criteria (2 listed)

Individuals below 18
Individuals with less than a 6-month prescription

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
GLP-1RAAll T2D adults treated with Glucagon-like peptide-1 receptor agonists (GLP-1RA) or initiating a GLP-1RA during the study period	Drug	GLP-1RA
SGLT2iSGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with Sodium/glucose cotransporter-2 inhibitors (SGLT2i) or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA	Drug	SGLT2i
InsulinInsulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i	Drug	Insulin
MiscellanyOther glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period and who were treated with other glucose-lowering agents during the study period	Drug	Miscellany

Primary outcome

Major acute cardiovascular events
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
In this work, this composite includes patients suffering from non-fatal acute myocardial infarction (AMI) and non-fatal stroke, transient ischemic attack (TIA), all-cause death, and, heart failure events occurring during the study period (from inclusion in the study until the event or the end of the study period, whichever came first).

11 secondary outcomes

Major acute cardiovascular events without heart failure
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
AMI
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Stroke
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Heart Failure
Time frame: Through study completion (from inclusion in the study until the event or the end of the study period, whichever came first)
all-cause death
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Renal progression
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
atrial fibrillation
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Hypoglycemia
Time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Persistence
Time frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Adherence
Time frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Therapeutic inertia
Time frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Background: PubMed 29675797Blonde L, Raccah D, Lew E, Meyers J, Nikonova E, Ajmera M, Davis KL, Bertolini M, Guerci B. Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin. Diabetes Ther. 2018 Jun;9(3):1169-1184. doi: 10.1007/s13300-018-0429-x. Epub 2018 Apr 19.
Background: PubMed 28801475Carls GS, Tuttle E, Tan RD, Huynh J, Yee J, Edelman SV, Polonsky WH. Understanding the Gap Between Efficacy in Randomized Controlled Trials and Effectiveness in Real-World Use of GLP-1 RA and DPP-4 Therapies in Patients With Type 2 Diabetes. Diabetes Care. 2017 Nov;40(11):1469-1478. doi: 10.2337/dc16-2725. Epub 2017 Aug 11.
Background: PubMed 29364585Chatterjee S, Davies MJ, Khunti K. What have we learnt from "real world" data, observational studies and meta-analyses. Diabetes Obes Metab. 2018 Feb;20 Suppl 1:47-58. doi: 10.1111/dom.13178.
Background: PubMed 27466235Conget I, Mauricio D, Ortega R, Detournay B; CHADIG Study investigators. Characteristics of patients with type 2 diabetes mellitus newly treated with GLP-1 receptor agonists (CHADIG Study): a cross-sectional multicentre study in Spain. BMJ Open. 2016 Jul 26;6(7):e010197. doi: 10.1136/bmjopen-2015-010197.
Background: PubMed 31028689Divino V, Boye KS, Lebrec J, DeKoven M, Norrbacka K. GLP-1 RA Treatment and Dosing Patterns Among Type 2 Diabetes Patients in Six Countries: A Retrospective Analysis of Pharmacy Claims Data. Diabetes Ther. 2019 Jun;10(3):1067-1088. doi: 10.1007/s13300-019-0615-5. Epub 2019 Apr 26.
Background: PubMed 28070733Divino V, DeKoven M, Khan FA, Boye KS, Sapin H, Norrbacka K. GLP-1 RA Treatment Patterns Among Type 2 Diabetes Patients in Five European Countries. Diabetes Ther. 2017 Feb;8(1):115-128. doi: 10.1007/s13300-016-0224-5. Epub 2017 Jan 9.
Background: PubMed 31673896Fadini GP, Frison V, Rigato M, Morieri ML, Simioni N, Tadiotto F, D'Ambrosio M, Paccagnella A, Lapolla A, Avogaro A. Trend 2010-2018 in the clinical use of GLP-1 receptor agonists for the treatment of type 2 diabetes in routine clinical practice: an observational study from Northeast Italy. Acta Diabetol. 2020 Mar;57(3):367-375. doi: 10.1007/s00592-019-01445-z. Epub 2019 Oct 31.
Background: PubMed 21457427Fu AZ, Qiu Y, Davies MJ, Radican L, Engel SS. Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes Obes Metab. 2011 Aug;13(8):765-9. doi: 10.1111/j.1463-1326.2011.01405.x.
Background: PubMed 27531506Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.
Background: PubMed 30677504Guerci B, Charbonnel B, Gourdy P, Hadjadj S, Hanaire H, Marre M, Verges B. Efficacy and adherence of glucagon-like peptide-1 receptor agonist treatment in patients with type 2 diabetes mellitus in real-life settings. Diabetes Metab. 2019 Dec;45(6):528-535. doi: 10.1016/j.diabet.2019.01.006. Epub 2019 Jan 21.
Background: PubMed 30291013Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.
Background: PubMed 31422062Kristensen SL, Rorth R, Jhund PS, Docherty KF, Sattar N, Preiss D, Kober L, Petrie MC, McMurray JJV. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet Diabetes Endocrinol. 2019 Oct;7(10):776-785. doi: 10.1016/S2213-8587(19)30249-9. Epub 2019 Aug 14.
Individual participant dataSharing planned: Undecided

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Obesity, run by Ana Palanca at 1 site in Spain.

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 2 inclusion and 2 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major acute cardiovascular events (time frame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.). 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 NCT05535322, which also lists 18 linked publications.

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 28 Sep 2022.