Diabetes Mellitus, Type 2Phase 3PIONEER PLUSNCT04707469
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
A Phase 3 study testing Oral semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 228 sites in 15 countries.
Trial summary
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg… 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?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,606 participants
- Where
- 228 sitesin 15 countries
- Study dates
- 15 Jan 2021to 8 Mar 2023
- Phase
- Phase 3
- 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
Who may be able to join
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- BMI equal to or above 25 kg/m^2
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
- No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
Show all 11Show fewer
- Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
- Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
- Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
- Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Who cannot join
- Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Trial locations and contacts
228 sites in 15 countries.
228 sites in 15 countries
United States84 sites
Arlington Family Res. Ctr Inc
Arlington, Texas, 76012-4637
University of Colorado Hospital
Aurora, Colorado, 80045
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808
Elite Clinical Trials
Blackfoot, Idaho, 83221
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352
American Clinical Trials
Buena Park, California, 90620
Mercury Str Med Grp, PLLC
Butte, Montana, 59701
UNC Diabetes Care Center_Chapel Hill
Chapel Hill, North Carolina, 27514
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Rapid Medical Research Inc
Cleveland, Ohio, 44122
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, 80906
Alliance for Multispec Res
Coral Gables, Florida, 33134
Corvallis Clinic PC Clinical Research Department
Corvallis, Oregon, 97330-3737
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
Lillestol Research LLC
Fargo, North Dakota, 58104
Aa Mrc Llc
Flint, Michigan, 48504
Care United Research, LLC
Forney, Texas, 75126
Prestige Clinical Research
Franklin, Ohio, 45005
Valley Research
Fresno, California, 93720
Macoupin Research Group
Gillespie, Illinois, 62033
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
Palmetto Clinical Research
Greenville, South Carolina, 29615
East West Med Res Inst
Honolulu, Hawaii, 96814
JCCT- Juno NW Houston
Houston, Texas, 77040
JCCT- Juno NW Houston
Houston, Texas, 77074
Southwest Clinical Trials
Houston, Texas, 77074
Family Practice Care Associates
Humble, Texas, 77338
Research Trials Worldwide LLC
Humble, Texas, 77338
Murphy Research Center
Humboldt, Tennessee, 38343
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, 83404-7596
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Northeast Research Institute
Jacksonville, Florida, 32204
Juno Research, LLC_Cary
Katy, Texas, 77450
Velocity Clin Res San Diego
La Mesa, California, 91942
Centex Studies, Inc._Lake Charles
Lake Charles, Louisiana, 70601
First Valley Medical Group
Lancaster, California, 93534
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
DCOL Ctr for Clin Res
Longview, Texas, 75605
Pacific Clinical Studies
Los Alamitos, California, 90720
Velocity Clin Res Los Angeles
Los Angeles, California, 90017
L-MARC Research Center
Louisville, Kentucky, 40213
Albert J Weisbrot
Mason, Ohio, 45040
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Solaris Clinical Research
Meridian, Idaho, 83646
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida, 33014
Health Res of Hampton Roads
Newport News, Virginia, 23606
York Clinical Research LLC
Norfolk, Virginia, 23504
Intend Research
Norman, Oklahoma, 73069
Diabetes Medical Center Of California
Northridge, California, 91325
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502
Univ of Nebraska Medical CTR
Omaha, Nebraska, 68198-3020
University of Nebraska Medical Center-Diabetes Center
Omaha, Nebraska, 68198-4120
Complete Health Research
Ormond Beach, Florida, 32174-6302
MD Medical Research
Oxon Hill, Maryland, 20745
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262
UnityPoint Health-Diabetes Care Center
Peoria, Illinois, 61603
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15236
Research Institute Of Dallas
Plano, Texas, 75093
Clinical Trial Res Assoc,Inc
Plantation, Florida, 33324
Progressive Medical Research
Port Orange, Florida, 32127
Gateway Research Center
Poway, California, 92064
Dominion Medical Associates
Richmond, Virginia, 23219
Endo Res Solutions Inc
Roswell, Georgia, 30076
VIP Trials
San Antonio, Texas, 78230
VIP Trials
San Antonio, Texas, 78231
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
Palmetto Clinical Research
Summerville, South Carolina, 29485
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, 66606
Premier Research Inc.
Trenton, New Jersey, 08611
Arcturus Healthcare, PLC.
Troy, Michigan, 48098
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
MassResearch, LLC
Waltham, Massachusetts, 02453
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801-2028
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
San Fernando Valley Hlth Inst, LLC
West Hills, California, 91304
Accellacare
Wilmington, North Carolina, 28401
India25 sites
Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Belgaum Diabetes Centre
Belagavi, Karnataka, 590001
KLES & Prabhakar Kore Hospital and Research Centre
Belagavi, Karnatka, 590010
Apollo Hospital
Delhi, New Delhi, 110076
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
Care Outpatient Centre
Hyderabad, Andhra Pradesh, 500034
Gandhi Hospital & Medical college
Hyderabad, Telangana, 500003
Gleneagles Hospitals
Hyderabad, Telangana, 500004
Osmania General Hospital
Hyderabad, Telangana, 500012
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, 682041
I.P.G.M.E & R Hospital
Kolkata, West Bengal, 700020
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054
Kurnool Medical Collage
Kurnool, Andhra Pradesh, 518002
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, 400012
Apollo Hospital, Navi Mumbai
Mumbai, Maharashtra, 400614
All India Institute of Medical Sciences
New Dehli, New Delhi, 110029
Fortis Hospital, Shalimar Bagh, New Delhi
New Delhi, National Capital Territory of Delhi, 110088
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Inamdar Multispeciality Hospital
Pune, Maharashtra, 411040
PGIMS Rohtak
Rohtak, Haryana, 124001
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004
Poland21 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, 15-435
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, 15-481
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Bialystok, 15-351
SNZOZ Lege Artis
Bialystok, 15-404
Centrum Kliniczno Badawcze
Elblag, 82-300
Centrum Badan Klinicznych PI-House
Gdansk, 80-546
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Uniwersyteckie Centrum Kliniczne im. prof. Gibinskiego, SUM
Katowice, 40-752
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, 90-338
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, 20-538
Centrum Zdrowia Metabolicznego
Poznan, Wielkopolskie Voivodeship, 60-589
Gaja Poradnie Lekarskie
Poznan, 61-251
Centrum Medyczne "Diabetika"
Radom, 26-600
NBR Polska Tomasz Klodawski
Warsaw, 00-710
SP CSK Klinika Diabetologii i Chorob Wewnetrznych
Warsaw, 02-097
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507
Centrum Medyczne Oporow
Wroclaw, 52-416
Prywatny Gabinet Janusz Gumprecht
Zabrze, 41-800
Bulgaria17 sites
MHAT - Blagoevgrad AD, Department of Internal Diseases
Blagoevgrad, 2700
Medical Center Zdrave Lom EOOD
Lom, 3600
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, 4400
"MHAT - Pazardzhik"
Pazardzhik, 4401
OCSOMCE - Dr. Albena Dinkova EOOD
Pleven, 5800
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, 4001
MHAT Sveta Karidad EAD
Plovdiv, 4004
MHAT Hadzhi Dimitar OOD
Sliven, 8800
Medical center Smolyan clinical research OOD
Smolyan, 4700
UMHAT "Aleksandrovska"
Sofia, 1431
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, 1431
Medical Institute of Ministry of interior
Sofia, 1606
UMHAT Sveta Marina EAD
Varna, 9010
AIPSMC Dr. Artin Magardichyan EOOD
Varna, 9020
MHAT- Hristo Botev AD
Vratsa, 3000
MHAT- Hristo Botev
Vratsa, 3001
MHAT Sveti Panteleimon - Yambol AD
Yambol, 8600
Canada15 sites
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, L6S 0C6
LMC Clin Res Inc. Calgary
Calgary, Alberta, T2H 2G4
C-endo Diab Endo Clin Calgery
Calgary, Alberta, T2V 4J2
LMC Clinical Res Thornhill
Concord, Ontario, L4K 4M2
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, M9R 4E1
Wharton Med Clin Trials
Hamilton, Ontario, L8L 5G8
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Applied Med Inf Res
Montreal, Quebec, H4A 3T2
LMC Research Inc. Ottawa
Nepean, Ontario, K2J 0V2
LMC Oakville
Oakville, Ontario, L6M 1M1
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, H4T 1Z9
Stayner Medical Clinic
Stayner, Ontario, L0M 1S0
Winterberry Family Medicine
Stoney Creek, Ontario, L8J 0B6
LMC Endo Centres Ltd.(Bayview)
Toronto, Ontario, M4G 3E8
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
Hungary11 sites
Óbudai Egészségügyi Centrum
Budapest, Pest County, 1036
Szőcs Depot Egészségügyi Szolgáltató Kft.
Budapest, 1042
Bajcsy-Zsilinszky Kórház
Budapest, 1106
Dr. Vass László Egészségügyi Intézmény Diab. Szakrendelés
Budapest, 1152
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
Debrecen, 4043
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
Debrecen, H-4032
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, 2900
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs, Baranya Vármegye, 7623
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, 8000
Tolna megyei Balassa János Kórház
Szekszárd, 7100
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, 9700
Slovakia10 sites
DIADA, s.r.o.
Bardejov, 08501
Diabetologicka ambulancia Diabetes care, s.r.o.
Hnúšťa, 98101
Diabetologicka ambulancia DIAMO s.r.o.
Kežmarok, 06001
MOMED, s.r.o
Kráľovský Chlmec, 077 01
IN-DIA s.r.o.
Lučenec, 984 01
Diabetologicka ambulancia MUDr. Alena Lomencikova, s.r.o
Martin, 036 01
DIABETOL, s.r.o.
Prešov, 080 01
OLIVER - MED s.r.o.
Rimavská Sobota, 979 01
MEDI-DIA s.r.o.
Sabinov, 08301
Diabetologicka ambulancia MUDr. Gabriela Zimova
Spišská Nová Ves, 052 01
Czechia9 sites
Ordinace pro choroby srdce
Chomutov, 430 02
Diabetologická a endokrinologická ambulance Hlučín
Hlučín, 748 01
Diahaza s.r.o.
Holešov, 76901
Diahelp - diabetologie
Pardubice, 530 02
DIALINE s.r.o.
Plzeň 3, 301 00
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00
DiaGolfova spol s.r.o.
Prague, 102 00
Diabet2 s.r.o.
Prague, 110 00
Diabetologická a endokrinologická ambulance Praha
Prague, 140 21
Germany8 sites
Institut für Klinische Forschung und Entwicklung
Berlin, 10437
Plassmann
Essen, 45359
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, 14612
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041
Wendisch/Dahl Hamburg (DZHW)
Hamburg, 22607
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, 66780
Australia7 sites
Fremantle Hospital
Fremantle, Western Australia, 6160
Barwon Health (The Geelong Hospital)
Geelong, Victoria, 3220
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
South Australian Endocrine Research
Keswick, South Australia, 5035
Liverpool Hospital
Liverpool, New South Wales, 2170
Core Research Centre
Milton, Queensland, 4064
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046
Croatia7 sites
Opca bolnica Bjelovar
Bjelovar, 43000
Klinicki bolnicki centar Osijek
Osijek, 31 000
KBC Rijeka, Endokrinologija
Rijeka, Primorje-Gorski Kotar County, 51 000
General Hospital Dr. Josip Bencevic_Diabetic department
Slavonski Brod, 35 000
Poliklinika Solmed
Zagreb, City of Zagreb, 10000
KB Dubrava, Zavod za endokrinologiju i dijabetes
Zagreb, 10000
Klinicka bolnica Sveti Duh
Zagreb, 10000
Estonia6 sites
Private Endocrnologist Dr Viitas
Pärnu, 80018
East Tallinn Central Hospital
Tallinn, 10138
Merelahe Family Doctors Centre
Tallinn, 10617
Estonian Diabetes Centre
Tallinn, 13419
Tartu University Hospital Internal Medicine Clinic
Tartu, 50406
SA Viljandi Haigla
Viljandi, 71024
Slovenia5 sites
General Hospital Celje
Celje, SI-3000
Healthcare Centre Koper
Koper, SI-6000
UKC Ljubljana, Endocrinology and Diabetes
Ljubljana, SI-1000
UKC Maribor - diabetes
Maribor, SI-2000
Healthcare Centre Nova Gorica
Nova Gorica, SI-5000
Taiwan2 sites
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan, 704
About this study
Official title: Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral semaglutide
- 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.
Oral semaglutideDrug
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oral semaglutide 50 mg | Experimental | Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68). Receives: Drug: Oral semaglutide |
| Oral semaglutide 25 mg | Experimental | Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68). Receives: Drug: Oral semaglutide |
| Oral semaglutide 14 mg | Active comparator | Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68). Receives: Drug: Oral semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Measured: Baseline (week 0), week 52
Secondary outcomes (38)
Change From Baseline in Body Weight (Week 52)
Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 52
Change From Baseline in HbA1c (Week 68)
Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Measured: Baseline (week 0), week 68
Change From Week 12 in HbA1c (Week 52)
Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Measured: Week 12, Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 52
Change From Baseline in FPG (Week 68)
Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)
Percentage of participants who achieved HbA1c <7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 52
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
Percentage of participants who achieved HbA1c <7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 68
Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)
Percentage of participants who achieved HbA1c <=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 52
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
Percentage of participants who achieved HbA1c <=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 68
Time to Event Analyses of Rescue Medication
Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Change From Baseline in Body Weight (Week 68)
Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Percentage Change From Baseline in Body Weight (Week 52)
Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 52
Percentage Change From Baseline in Body Weight (Week 68)
Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Percentage Change From Week 12 in Body Weight (Week 52)
Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Week 12, Week 52
Change From Baseline in Body Mass Index (BMI) (Week 52)
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 52
Change From Baseline in BMI (Week 68)
Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Change From Baseline in Waist Circumference (Week 52)
Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 52
Change From Baseline in Waist Circumference (Week 68)
Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline (week 0), week 68
Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)
Percentage of participants who achieved weight loss >= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 52
Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)
Percentage of participants who achieved weight loss >= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 68
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)
Percentage of participants who achieved weight loss >= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 52
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
Percentage of participants who achieved weight loss >= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: At week 68
Change From Baseline in Total Cholesterol (Week 52)
Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 52
Change From Baseline in Total Cholesterol (Week 68)
Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 68
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 52
Change From Baseline in LDL (Week 68)
Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 68
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 52
Change From Baseline in HDL (Week 68)
Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 68
Change From Baseline in Triglycerides (Week 52)
Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 52
Change From Baseline in Triglycerides (Week 68)
Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Measured: Baseline, Week 68
Number of Adverse Events
An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: From baseline (week 0) up to week 73
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)
Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was < 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: From baseline (week 0) up to week 68
Change From Baseline in Systolic Blood Pressure (Week 52)
Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 52
Change From Baseline in Systolic Blood Pressure (Week 68)
Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 68
Change From Baseline in Diastolic Blood Pressure (Week 52)
Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 52
Change From Baseline in Diastolic Blood Pressure (Week 68)
Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 68
Change From Baseline in Pulse (Week 52)
Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 52
Change From Baseline in Pulse (Week 68)
Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Measured: Baseline (week 0), week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Jan 2021
- Primary completion7 Mar 2023
- Study completion8 Mar 2023
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 Novo Nordisk A/SThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707469
- Sponsor's protocol ID
- NN9924-4635
- Other IDs
- U1111-1247-0210, 2020-000299-39
- Acronym
- PIONEER PLUS
- Status last verified
- Nov 2025
- First submitted
- 12 Jan 2021
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. 2023 Aug 26;402(10403):693-704. doi: 10.1016/S0140-6736(23)01127-3. Epub 2023 Jun 26.
PubMed 37385279
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04707469
- Acronym / sponsor ID
- PIONEER PLUS / NN9924-4635
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,606 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral semaglutide 50 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68). |
| Oral semaglutide 25 mg | Experimental | Drug: Oral semaglutideParticipants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68). |
| Oral semaglutide 14 mg | Active comparator | Drug: Oral semaglutideParticipants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- BMI equal to or above 25 kg/m^2
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
Key exclusion criteria (3 listed)
- Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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 |
|---|---|---|
| Oral semaglutideParticipants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks. | Drug | Oral semaglutide 14 mg, Oral semaglutide 25 mg, Oral semaglutide 50 mg |
Primary outcome
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
Time frame: Baseline (week 0), week 52
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
38 secondary outcomes
Change From Baseline in Body Weight (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in HbA1c (Week 68)
Time frame: Baseline (week 0), week 68
Change From Week 12 in HbA1c (Week 52)
Time frame: Week 12, Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in FPG (Week 68)
Time frame: Baseline (week 0), week 68
Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)
Time frame: At week 52
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
Time frame: At week 68
Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)
Time frame: At week 52
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
Time frame: At week 68
Time to Event Analyses of Rescue Medication
Time frame: Baseline (week 0), week 68
Change From Baseline in Body Weight (Week 68)
Time frame: Baseline (week 0), week 68
Percentage Change From Baseline in Body Weight (Week 52)
Time frame: Baseline (week 0), week 52
Percentage Change From Baseline in Body Weight (Week 68)
Time frame: Baseline (week 0), week 68
Percentage Change From Week 12 in Body Weight (Week 52)
Time frame: Week 12, Week 52
Change From Baseline in Body Mass Index (BMI) (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in BMI (Week 68)
Time frame: Baseline (week 0), week 68
Change From Baseline in Waist Circumference (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in Waist Circumference (Week 68)
Time frame: Baseline (week 0), week 68
Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)
Time frame: At week 52
Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)
Time frame: At week 68
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)
Time frame: At week 52
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
Time frame: At week 68
Change From Baseline in Total Cholesterol (Week 52)
Time frame: Baseline, Week 52
Change From Baseline in Total Cholesterol (Week 68)
Time frame: Baseline, Week 68
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
Time frame: Baseline, Week 52
Change From Baseline in LDL (Week 68)
Time frame: Baseline, Week 68
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
Time frame: Baseline, Week 52
Change From Baseline in HDL (Week 68)
Time frame: Baseline, Week 68
Change From Baseline in Triglycerides (Week 52)
Time frame: Baseline, Week 52
Change From Baseline in Triglycerides (Week 68)
Time frame: Baseline, Week 68
Number of Adverse Events
Time frame: From baseline (week 0) up to week 73
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline (week 0) up to week 68
Change From Baseline in Systolic Blood Pressure (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in Systolic Blood Pressure (Week 68)
Time frame: Baseline (week 0), week 68
Change From Baseline in Diastolic Blood Pressure (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in Diastolic Blood Pressure (Week 68)
Time frame: Baseline (week 0), week 68
Change From Baseline in Pulse (Week 52)
Time frame: Baseline (week 0), week 52
Change From Baseline in Pulse (Week 68)
Time frame: Baseline (week 0), week 68
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37385279Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. 2023 Aug 26;402(10403):693-704. doi: 10.1016/S0140-6736(23)01127-3. Epub 2023 Jun 26.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
228 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 228 sites in 15 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 11 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 228 sites in United States, India, Poland, Bulgaria, Canada and 10 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2024). 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?
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) (time frame: Baseline (week 0), week 52). 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 NCT04707469, 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 9 Dec 2025.