Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
NCT ID: NCT04707469
Last Updated: 2025-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1606 participants
INTERVENTIONAL
2021-01-15
2023-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral semaglutide 50 mg
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).
Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Oral semaglutide 25 mg
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).
Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Oral semaglutide 14 mg
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).
Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Interventions
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Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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).
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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American Clinical Trials
Buena Park, California, United States
Valley Research
Fresno, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Gateway Research Center
Poway, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
San Fernando Valley Hlth Inst, LLC
West Hills, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Alliance for Multispec Res
Coral Gables, Florida, United States
Northeast Research Institute
Jacksonville, Florida, United States
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida, United States
Complete Health Research
Ormond Beach, Florida, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Macoupin Research Group
Gillespie, Illinois, United States
UnityPoint Health-Diabetes Care Center
Peoria, Illinois, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States
Centex Studies, Inc._Lake Charles
Lake Charles, Louisiana, United States
MD Medical Research
Oxon Hill, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
MassResearch, LLC
Waltham, Massachusetts, United States
Aa Mrc Llc
Flint, Michigan, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
University of Nebraska Medical Center-Diabetes Center
Omaha, Nebraska, United States
Premier Research Inc.
Trenton, New Jersey, United States
UNC Diabetes Care Center_Chapel Hill
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Rapid Medical Research Inc
Cleveland, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Albert J Weisbrot
Mason, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Corvallis Clinic PC Clinical Research Department
Corvallis, Oregon, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, United States
Palmetto Clinical Research
Greenville, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Holston Medical Group Pc
Bristol, Tennessee, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Murphy Research Center
Humboldt, Tennessee, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Care United Research, LLC
Forney, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Family Practice Care Associates
Humble, Texas, United States
Research Trials Worldwide LLC
Humble, Texas, United States
Juno Research, LLC_Cary
Katy, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Research Institute Of Dallas
Plano, Texas, United States
VIP Trials
San Antonio, Texas, United States
VIP Trials
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Dominion Medical Associates
Richmond, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Core Research Centre
Milton, Queensland, Australia
South Australian Endocrine Research
Keswick, South Australia, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, Australia
Barwon Health (The Geelong Hospital)
Geelong, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
MHAT - Blagoevgrad AD, Department of Internal Diseases
Blagoevgrad, , Bulgaria
Medical Center Zdrave Lom EOOD
Lom, , Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, , Bulgaria
"MHAT - Pazardzhik"
Pazardzhik, , Bulgaria
OCSOMCE - Dr. Albena Dinkova EOOD
Pleven, , Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, , Bulgaria
MHAT Sveta Karidad EAD
Plovdiv, , Bulgaria
MHAT Hadzhi Dimitar OOD
Sliven, , Bulgaria
Medical center Smolyan clinical research OOD
Smolyan, , Bulgaria
UMHAT "Aleksandrovska"
Sofia, , Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, , Bulgaria
Medical Institute of Ministry of interior
Sofia, , Bulgaria
UMHAT Sveta Marina EAD
Varna, , Bulgaria
AIPSMC Dr. Artin Magardichyan EOOD
Varna, , Bulgaria
MHAT- Hristo Botev AD
Vratsa, , Bulgaria
MHAT- Hristo Botev
Vratsa, , Bulgaria
MHAT Sveti Panteleimon - Yambol AD
Yambol, , Bulgaria
LMC Clin Res Inc. Calgary
Calgary, Alberta, Canada
C-endo Diab Endo Clin Calgery
Calgary, Alberta, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, Canada
LMC Clinical Res Thornhill
Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, Canada
LMC Oakville
Oakville, Ontario, Canada
Stayner Medical Clinic
Stayner, Ontario, Canada
Winterberry Family Medicine
Stoney Creek, Ontario, Canada
LMC Endo Centres Ltd.(Bayview)
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Applied Med Inf Res
Montreal, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, Canada
Poliklinika Solmed
Zagreb, City of Zagreb, Croatia
KBC Rijeka, Endokrinologija
Rijeka, Primorje-Gorski Kotar County, Croatia
Opca bolnica Bjelovar
Bjelovar, , Croatia
Klinicki bolnicki centar Osijek
Osijek, , Croatia
General Hospital Dr. Josip Bencevic_Diabetic department
Slavonski Brod, , Croatia
KB Dubrava, Zavod za endokrinologiju i dijabetes
Zagreb, , Croatia
Klinicka bolnica Sveti Duh
Zagreb, , Croatia
Ordinace pro choroby srdce
Chomutov, , Czechia
Diabetologická a endokrinologická ambulance Hlučín
Hlučín, , Czechia
Diahaza s.r.o.
Holešov, , Czechia
Diahelp - diabetologie
Pardubice, , Czechia
DIALINE s.r.o.
Plzeň 3, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
DiaGolfova spol s.r.o.
Prague, , Czechia
Diabet2 s.r.o.
Prague, , Czechia
Diabetologická a endokrinologická ambulance Praha
Prague, , Czechia
Private Endocrnologist Dr Viitas
Pärnu, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
Merelahe Family Doctors Centre
Tallinn, , Estonia
Estonian Diabetes Centre
Tallinn, , Estonia
Tartu University Hospital Internal Medicine Clinic
Tartu, , Estonia
SA Viljandi Haigla
Viljandi, , Estonia
Institut für Klinische Forschung und Entwicklung
Berlin, , Germany
Plassmann
Essen, , Germany
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, , Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, , Germany
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs, Baranya Vármegye, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház
Budapest, , Hungary
Dr. Vass László Egészségügyi Intézmény Diab. Szakrendelés
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
Debrecen, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
Debrecen, , Hungary
Tolna megyei Balassa János Kórház
Szekszárd, , Hungary
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, , Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Care Outpatient Centre
Hyderabad, Andhra Pradesh, India
Kurnool Medical Collage
Kurnool, Andhra Pradesh, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
PGIMS Rohtak
Rohtak, Haryana, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Belgaum Diabetes Centre
Belagavi, Karnataka, India
KLES & Prabhakar Kore Hospital and Research Centre
Belagavi, Karnatka, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
Apollo Hospital, Navi Mumbai
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
Inamdar Multispeciality Hospital
Pune, Maharashtra, India
Fortis Hospital, Shalimar Bagh, New Delhi
New Delhi, National Capital Territory of Delhi, India
Apollo Hospital
Delhi, New Delhi, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, India
Gleneagles Hospitals
Hyderabad, Telangana, India
Osmania General Hospital
Hyderabad, Telangana, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, India
I.P.G.M.E & R Hospital
Kolkata, West Bengal, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, Poland
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, Poland
Centrum Zdrowia Metabolicznego
Poznan, Wielkopolskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Bialystok, , Poland
SNZOZ Lege Artis
Bialystok, , Poland
Centrum Kliniczno Badawcze
Elblag, , Poland
Centrum Badan Klinicznych PI-House
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne im. prof. Gibinskiego, SUM
Katowice, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
Gaja Poradnie Lekarskie
Poznan, , Poland
Centrum Medyczne "Diabetika"
Radom, , Poland
NBR Polska Tomasz Klodawski
Warsaw, , Poland
SP CSK Klinika Diabetologii i Chorob Wewnetrznych
Warsaw, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Prywatny Gabinet Janusz Gumprecht
Zabrze, , Poland
Manati Ctr For Clin Research
Manatí, , Puerto Rico
DIADA, s.r.o.
Bardejov, , Slovakia
Diabetologicka ambulancia Diabetes care, s.r.o.
Hnúšťa, , Slovakia
Diabetologicka ambulancia DIAMO s.r.o.
Kežmarok, , Slovakia
MOMED, s.r.o
Kráľovský Chlmec, , Slovakia
IN-DIA s.r.o.
Lučenec, , Slovakia
Diabetologicka ambulancia MUDr. Alena Lomencikova, s.r.o
Martin, , Slovakia
DIABETOL, s.r.o.
Prešov, , Slovakia
OLIVER - MED s.r.o.
Rimavská Sobota, , Slovakia
MEDI-DIA s.r.o.
Sabinov, , Slovakia
Diabetologicka ambulancia MUDr. Gabriela Zimova
Spišská Nová Ves, , Slovakia
General Hospital Celje
Celje, , Slovenia
Healthcare Centre Koper
Koper, , Slovenia
UKC Ljubljana, Endocrinology and Diabetes
Ljubljana, , Slovenia
UKC Maribor - diabetes
Maribor, , Slovenia
Healthcare Centre Nova Gorica
Nova Gorica, , Slovenia
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1247-0210
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000299-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9924-4635
Identifier Type: -
Identifier Source: org_study_id
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