NCT04707469

Brief 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 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®.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,606

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2021

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
14 countries

218 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 3, 2024

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

January 12, 2021

Results QC Date

March 5, 2024

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (week 0), week 52

Secondary Outcomes (38)

  • Change From Baseline in Body Weight (Week 52)

    Baseline (week 0), week 52

  • Change From Baseline in HbA1c (Week 68)

    Baseline (week 0), week 68

  • Change From Week 12 in HbA1c (Week 52)

    Week 12, Week 52

  • Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)

    Baseline (week 0), week 52

  • Change From Baseline in FPG (Week 68)

    Baseline (week 0), week 68

  • +33 more secondary outcomes

Study Arms (3)

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).

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).

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).

Drug: Oral semaglutide

Interventions

Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Oral semaglutide 14 mgOral semaglutide 25 mgOral semaglutide 50 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \*:
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (228)

American Clinical Trials

Buena Park, California, 90620, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Velocity Clin Res San Diego

La Mesa, California, 91942, United States

Location

First Valley Medical Group

Lancaster, California, 93534, United States

Location

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

Diabetes Medical Center Of California

Northridge, California, 91325, United States

Location

Desert Oasis Hlthcr Med Group

Palm Springs, California, 92262, United States

Location

Gateway Research Center

Poway, California, 92064, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

San Fernando Valley Hlth Inst, LLC

West Hills, California, 91304, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Optumcare Clinical Trials,LLC-Golden

Colorado Springs, Colorado, 80906, United States

Location

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

Location

Alliance for Multispec Res

Coral Gables, Florida, 33134, United States

Location

Northeast Research Institute

Jacksonville, Florida, 32204, United States

Location

San Marcus Res Clin Miami Lakes

Miami Lakes, Florida, 33014, United States

Location

Complete Health Research

Ormond Beach, Florida, 32174-6302, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Endo Res Solutions Inc

Roswell, Georgia, 30076, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Rocky Mt Clin Res, LLC

Idaho Falls, Idaho, 83404-7596, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Macoupin Research Group

Gillespie, Illinois, 62033, United States

Location

UnityPoint Health-Diabetes Care Center

Peoria, Illinois, 61603, United States

Location

Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

Location

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States

Location

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Pennington Biom Res Ctr

Baton Rouge, Louisiana, 70808, United States

Location

Centex Studies, Inc._Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

Location

MassResearch, LLC

Waltham, Massachusetts, 02453, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Arcturus Healthcare, PLC.

Troy, Michigan, 48098, United States

Location

Mercury Str Med Grp, PLLC

Butte, Montana, 59701, United States

Location

Univ of Nebraska Medical CTR

Omaha, Nebraska, 68198-3020, United States

Location

University of Nebraska Medical Center-Diabetes Center

Omaha, Nebraska, 68198-4120, United States

Location

Premier Research Inc.

Trenton, New Jersey, 08611, United States

Location

UNC Diabetes Care Center_Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Rapid Medical Research Inc

Cleveland, Ohio, 44122, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Albert J Weisbrot

Mason, Ohio, 45040, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Corvallis Clinic PC Clinical Research Department

Corvallis, Oregon, 97330-3737, United States

Location

Preferred Primary Care Physicians_Pittsburgh

Pittsburgh, Pennsylvania, 15236, United States

Location

Palmetto Clinical Research

Greenville, South Carolina, 29615, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Holston Medical Group Pc

Bristol, Tennessee, 37620-7352, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Murphy Research Center

Humboldt, Tennessee, 38343, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Arlington Family Res. Ctr Inc

Arlington, Texas, 76012-4637, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Care United Research, LLC

Forney, Texas, 75126, United States

Location

JCCT- Juno NW Houston

Houston, Texas, 77040, United States

Location

JCCT- Juno NW Houston

Houston, Texas, 77074, United States

Location

Southwest Clinical Trials

Houston, Texas, 77074, United States

Location

Family Practice Care Associates

Humble, Texas, 77338, United States

Location

Research Trials Worldwide LLC

Humble, Texas, 77338, United States

Location

Juno Research, LLC_Cary

Katy, Texas, 77450, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Research Institute Of Dallas

Plano, Texas, 75093, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

VIP Trials

San Antonio, Texas, 78231, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Simcare Medical Research, LLC

Sugar Land, Texas, 77478, United States

Location

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

Location

York Clinical Research LLC

Norfolk, Virginia, 23504, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801-2028, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Core Research Centre

Milton, Queensland, 4064, Australia

Location

South Australian Endocrine Research

Keswick, South Australia, 5035, Australia

Location

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, 5046, Australia

Location

Barwon Health (The Geelong Hospital)

Geelong, Victoria, 3220, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

MHAT - Blagoevgrad AD, Department of Internal Diseases

Blagoevgrad, 2700, Bulgaria

Location

Medical Center Zdrave Lom EOOD

Lom, 3600, Bulgaria

Location

UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases

Pazardzhik, 4400, Bulgaria

Location

"MHAT - Pazardzhik"

Pazardzhik, 4401, Bulgaria

Location

OCSOMCE - Dr. Albena Dinkova EOOD

Pleven, 5800, Bulgaria

Location

UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic

Plovdiv, 4001, Bulgaria

Location

MHAT Sveta Karidad EAD

Plovdiv, 4004, Bulgaria

Location

MHAT Hadzhi Dimitar OOD

Sliven, 8800, Bulgaria

Location

Medical center Smolyan clinical research OOD

Smolyan, 4700, Bulgaria

Location

UMHAT "Aleksandrovska"

Sofia, 1431, Bulgaria

Location

USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology

Sofia, 1431, Bulgaria

Location

Medical Institute of Ministry of interior

Sofia, 1606, Bulgaria

Location

UMHAT Sveta Marina EAD

Varna, 9010, Bulgaria

Location

AIPSMC Dr. Artin Magardichyan EOOD

Varna, 9020, Bulgaria

Location

MHAT- Hristo Botev AD

Vratsa, 3000, Bulgaria

Location

MHAT- Hristo Botev

Vratsa, 3001, Bulgaria

Location

MHAT Sveti Panteleimon - Yambol AD

Yambol, 8600, Bulgaria

Location

LMC Clin Res Inc. Calgary

Calgary, Alberta, T2H 2G4, Canada

Location

C-endo Diab Endo Clin Calgery

Calgary, Alberta, T2V 4J2, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

LMC ClinRsrh Inc.Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

LMC Clinical Res Thornhill

Concord, Ontario, L4K 4M2, Canada

Location

LMC Endo Ctr (Etobicoke) Ltd

Etobicoke, Ontario, M9R 4E1, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

LMC Research Inc. Ottawa

Nepean, Ontario, K2J 0V2, Canada

Location

LMC Oakville

Oakville, Ontario, L6M 1M1, Canada

Location

Stayner Medical Clinic

Stayner, Ontario, L0M 1S0, Canada

Location

Winterberry Family Medicine

Stoney Creek, Ontario, L8J 0B6, Canada

Location

LMC Endo Centres Ltd.(Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Applied Med Inf Res

Montreal, Quebec, H4A 3T2, Canada

Location

LMC Clin Rsrch Inc. (Montreal)

Saint-Laurent, Quebec, H4T 1Z9, Canada

Location

Poliklinika Solmed

Zagreb, City of Zagreb, 10000, Croatia

Location

KBC Rijeka, Endokrinologija

Rijeka, Primorje-Gorski Kotar County, 51 000, Croatia

Location

Opca bolnica Bjelovar

Bjelovar, 43000, Croatia

Location

Klinicki bolnicki centar Osijek

Osijek, 31 000, Croatia

Location

General Hospital Dr. Josip Bencevic_Diabetic department

Slavonski Brod, 35 000, Croatia

Location

KB Dubrava, Zavod za endokrinologiju i dijabetes

Zagreb, 10000, Croatia

Location

Klinicka bolnica Sveti Duh

Zagreb, 10000, Croatia

Location

Ordinace pro choroby srdce

Chomutov, 430 02, Czechia

Location

Diabetologická a endokrinologická ambulance Hlučín

Hlučín, 748 01, Czechia

Location

Diahaza s.r.o.

Holešov, 76901, Czechia

Location

Diahelp - diabetologie

Pardubice, 530 02, Czechia

Location

DIALINE s.r.o.

Plzeň 3, 301 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 00, Czechia

Location

DiaGolfova spol s.r.o.

Prague, 102 00, Czechia

Location

Diabet2 s.r.o.

Prague, 110 00, Czechia

Location

Diabetologická a endokrinologická ambulance Praha

Prague, 140 21, Czechia

Location

Private Endocrnologist Dr Viitas

Pärnu, 80018, Estonia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, 10617, Estonia

Location

Estonian Diabetes Centre

Tallinn, 13419, Estonia

Location

Tartu University Hospital Internal Medicine Clinic

Tartu, 50406, Estonia

Location

SA Viljandi Haigla

Viljandi, 71024, Estonia

Location

Institut für Klinische Forschung und Entwicklung

Berlin, 10437, Germany

Location

Plassmann

Essen, 45359, Germany

Location

Zentrum für klinische Forschung, Dr. med. Lüdemann

Falkensee, 14612, Germany

Location

Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

Hamburg, 22041, Germany

Location

Wendisch/Dahl Hamburg (DZHW)

Hamburg, 22607, Germany

Location

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

Location

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

Location

Praxis Dr. med. Wenzl-Bauer

Rehlingen-Siersburg, 66780, Germany

Location

PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

Pécs, Baranya Vármegye, 7623, Hungary

Location

Komáromi Selye János Kórház

Komárom, Komárom-Esztergom, 2900, Hungary

Location

Óbudai Egészségügyi Centrum

Budapest, Pest County, 1036, Hungary

Location

Szőcs Depot Egészségügyi Szolgáltató Kft.

Budapest, 1042, Hungary

Location

Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary

Location

Dr. Vass László Egészségügyi Intézmény Diab. Szakrendelés

Budapest, 1152, Hungary

Location

Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület

Debrecen, 4043, Hungary

Location

Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika

Debrecen, H-4032, Hungary

Location

Tolna megyei Balassa János Kórház

Szekszárd, 7100, Hungary

Location

Fejér Megyei Szent György Oktatókórház

Székesfehérvár, 8000, Hungary

Location

Vas Vármegyei Markusovszky Egyetemi Oktatókórház

Szombathely, 9700, Hungary

Location

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

Location

Care Outpatient Centre

Hyderabad, Andhra Pradesh, 500034, India

Location

Kurnool Medical Collage

Kurnool, Andhra Pradesh, 518002, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395002, India

Location

PGIMS Rohtak

Rohtak, Haryana, 124001, India

Location

Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Belgaum Diabetes Centre

Belagavi, Karnataka, 590001, India

Location

KLES & Prabhakar Kore Hospital and Research Centre

Belagavi, Karnatka, 590010, India

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Seth GS medical college and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Apollo Hospital, Navi Mumbai

Mumbai, Maharashtra, 400614, India

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, 411004, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

Inamdar Multispeciality Hospital

Pune, Maharashtra, 411040, India

Location

Fortis Hospital, Shalimar Bagh, New Delhi

New Delhi, National Capital Territory of Delhi, 110088, India

Location

Apollo Hospital

Delhi, New Delhi, 110076, India

Location

All India Institute of Medical Sciences

New Dehli, New Delhi, 110029, India

Location

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

Location

Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, 632004, India

Location

Gandhi Hospital & Medical college

Hyderabad, Telangana, 500003, India

Location

Gleneagles Hospitals

Hyderabad, Telangana, 500004, India

Location

Osmania General Hospital

Hyderabad, Telangana, 500012, India

Location

MV Hospital and Research Centre

Lucknow, Uttar Pradesh, 226003, India

Location

I.P.G.M.E & R Hospital

Kolkata, West Bengal, 700020, India

Location

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, 700054, India

Location

NZOZ Przychodnia Specjalistyczna Medica

Lublin, Lubelski, 20-538, Poland

Location

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, Podlaskie Voivodeship, 15-435, Poland

Location

Kresmed Sp. z o. o.

Bialystok, Podlaskie Voivodeship, 15-481, Poland

Location

Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, 60-589, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Osteo Medic s.c. Artur Racewicz Jerzy Supronik

Bialystok, 15-351, Poland

Location

SNZOZ Lege Artis

Bialystok, 15-404, Poland

Location

Centrum Kliniczno Badawcze

Elblag, 82-300, Poland

Location

Centrum Badan Klinicznych PI-House

Gdansk, 80-546, Poland

Location

Uniwersyteckie Centrum Kliniczne im. prof. Gibinskiego, SUM

Katowice, 40-752, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

Lodz, 90-338, Poland

Location

Gaja Poradnie Lekarskie

Poznan, 61-251, Poland

Location

Centrum Medyczne "Diabetika"

Radom, 26-600, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

SP CSK Klinika Diabetologii i Chorob Wewnetrznych

Warsaw, 02-097, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Prywatny Gabinet Janusz Gumprecht

Zabrze, 41-800, Poland

Location

Manati Ctr For Clin Research

Manatí, 00674, Puerto Rico

Location

DIADA, s.r.o.

Bardejov, 08501, Slovakia

Location

Diabetologicka ambulancia Diabetes care, s.r.o.

Hnúšťa, 98101, Slovakia

Location

Diabetologicka ambulancia DIAMO s.r.o.

Kežmarok, 06001, Slovakia

Location

MOMED, s.r.o

Kráľovský Chlmec, 077 01, Slovakia

Location

IN-DIA s.r.o.

Lučenec, 984 01, Slovakia

Location

Diabetologicka ambulancia MUDr. Alena Lomencikova, s.r.o

Martin, 036 01, Slovakia

Location

DIABETOL, s.r.o.

Prešov, 080 01, Slovakia

Location

OLIVER - MED s.r.o.

Rimavská Sobota, 979 01, Slovakia

Location

MEDI-DIA s.r.o.

Sabinov, 08301, Slovakia

Location

Diabetologicka ambulancia MUDr. Gabriela Zimova

Spišská Nová Ves, 052 01, Slovakia

Location

General Hospital Celje

Celje, SI-3000, Slovenia

Location

Healthcare Centre Koper

Koper, SI-6000, Slovenia

Location

UKC Ljubljana, Endocrinology and Diabetes

Ljubljana, SI-1000, Slovenia

Location

UKC Maribor - diabetes

Maribor, SI-2000, Slovenia

Location

Healthcare Centre Nova Gorica

Nova Gorica, SI-5000, Slovenia

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Clinical Reporting Office (2834)
Organization
Novo Nordisk A/S

Study Officials

  • Clinical Transparency (dept. 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 13, 2021

Study Start

January 15, 2021

Primary Completion

March 7, 2023

Study Completion

March 8, 2023

Last Updated

December 9, 2025

Results First Posted

April 3, 2024

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations