Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes (PIONEER PLUS)

March 5, 2024 updated by: Novo Nordisk A/S

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1606

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Milton, Queensland, Australia, 4064
        • Core Research Centre
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • South Australian Endocrine Research
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health (The Geelong Hospital)
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • "MHAT-Blagoevgrad", Department of Internal Diseases
      • Lom, Bulgaria, 3600
        • Medical Center Zdrave Lom
      • Pazardzhik, Bulgaria, 4401
        • "MHAT - Pazardzhik"
      • Pazardzhik, Bulgaria, 4400
        • UMHAT Pulmed, Department of endocrinology
      • Pleven, Bulgaria, 5800
        • OCSOMCE - Dr. Albena Dinkova EOOD
      • Plovdiv, Bulgaria, 4001
        • UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
      • Plovdiv, Bulgaria, 4004
        • 'MHAT Sveta Karidad' EAD
      • Sliven, Bulgaria, 8800
        • 'MHAT Hadzhi Dimitar' OOD
      • Smolyan, Bulgaria, 4700
        • "Medical center Smolyan clinical research" OOD
      • Sofia, Bulgaria, 1431
        • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
      • Sofia, Bulgaria, 1431
        • UMHAT "Aleksandrovska"
      • Sofia, Bulgaria, 1606
        • Medical Institute of Ministry of interior
      • Varna, Bulgaria, 9020
        • AIPSMC Dr. Artin Magardichyan EOOD
      • Varna, Bulgaria, 9010
        • UMHAT Sveta Marina EAD
      • Vratsa, Bulgaria, 3001
        • MHAT- Hristo Botev
      • Yambol, Bulgaria, 8600
        • "MHAT "Sveti Panteleimon" - Yambol" AD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • LMC Clin Res Inc. Calgary
      • Calgary, Alberta, Canada, T2V 4J2
        • C-endo Diab Endo Clin Calgery
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G.A. Research Associates Ltd.
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • LMC ClinRsrh Inc.Brampton
      • Concord, Ontario, Canada, L4K 4M2
        • LMC (Thornhill)
      • Etobicoke, Ontario, Canada, M9R 4E1
        • LMC Endo Ctr (Etobicoke) Ltd
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Med Clin Trials
      • Nepean, Ontario, Canada, K2J 0V2
        • LMC Research Inc. Ottawa
      • Oakville, Ontario, Canada, L6M 1M1
        • LMC Oakville
      • Stoney Creek, Ontario, Canada, L8J 0B6
        • Winterberry Family Medicine
      • Toronto, Ontario, Canada, M4G 3E8
        • LMC Endo Centres Ltd.(Bayview)
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Med Inf Res
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clin Rsrch Inc. (Montreal)
  • Croatia
      • Osijek, Croatia, 31 000
        • Klinicki bolnicki centar Osijek
      • Slavonski Brod, Croatia, 35 000
        • Opca bolnica Dr. Josip Bencevic
      • Zagreb, Croatia, 10000
        • Klinicka bolnica Sveti Duh
      • Zagreb, Croatia, 10000
        • KB Dubrava, Zavod za endokrinologiju i dijabetes
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed
    • Primorsko - Goranska Županija
      • Rijeka, Primorsko - Goranska Županija, Croatia, 51 000
        • KBC Rijeka, Endokrinologija
  • Czechia
      • Chomutov, Czechia, 430 02
        • Ordinace pro choroby srdce
      • Holešov, Czechia, 76901
        • Diahaza s.r.o.
      • Plzeň 3, Czechia, 301 00
        • DIALINE s.r.o.
      • Praha, Czechia, 100 00
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha, Czechia, 140 21
        • Diabetologická a endokrinologická ambulance Praha
  • Estonia
      • Pärnu, Estonia, 80018
        • Private Endocrnologist Dr Viitas
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • Merelahe Family Doctors Centre
      • Tallinn, Estonia, 13419
        • Estonian Diabetes Centre
      • Tartu, Estonia, 50406
        • Tartu University Hospital Internal Medicine Clinic
  • Germany
      • Berlin, Germany, 10437
        • Institut für Klinische Forschung und Entwicklung
      • Essen, Germany, 45359
        • Plassmann
      • Falkensee, Germany, 14612
        • Zentrum für klinische Forschung, Dr. med. Lüdemann
      • Hamburg, Germany, 22607
        • Wendisch/Dahl Hamburg
      • Hamburg, Germany, 22041
        • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Oldenburg in Holstein, Germany, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Rehlingen-Siersburg, Germany, 66780
        • Praxis Dr. med. Wenzl-Bauer
  • Hungary
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Hungary, 1106
        • Bajcsy-Zsilinszky Kórház
      • Budapest, Hungary, 1042
        • Szőcs Depot Egészségügyi Szolgáltató Kft.
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
      • Debrecen, Hungary, 4043
        • Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
      • Pécs, Hungary, 7623
        • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
      • Szombathely, Hungary, H-9700
        • Markusovszky Egyetemi Oktatokorhaz
      • Székesfehérvár, Hungary, 8000
        • Fejér Megyei Szent György Oktatókórház
    • Komárom-Esztergom
      • Komárom, Komárom-Esztergom, Hungary, 2900
        • Selye János Kórház és Rendelőintézet
  • India
    • A.p.
      • Hyderabad, A.p., India, 500 012
        • Osmania General Hospital
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Specialty Hospitals
      • Hyderabad, Andhra Pradesh, India, 500034
        • Care Outpatient Centre
    • Delhi
      • New Delhi, Delhi, India, 110088
        • Fortis Hospital, Shalimar Bagh, New Delhi
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt. Ltd.
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIMS Rohtak
    • Karnatka
      • Belgaum, Karnatka, India, 590010
        • KLES & Prabhakar Kore Hospital and Research Centre
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute Of Medical Sciences & Research Centre
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth GS medical college and KEM Hospital
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
      • Pune, Maharashtra, India, 411040
        • Inamdar Multispeciality Hospital
    • New Delhi
      • Delhi, New Delhi, India, 110076
        • Apollo Hospital
      • New Dehli, New Delhi, India, 110029
        • All India Institute of Medical Sciences
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Hospital, Vellore
    • Telengana
      • Hyderabad, Telengana, India, 500003
        • Gandhi Hospital & Medical college
      • Hyderabad, Telengana, India, 500004
        • Gleneagles Global Hospitals
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • MV Hospital and Research Centre
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospital, Kolkata
      • Kolkata, West Bengal, India, 700020
        • I.P.G.M.E & R Hospital
  • Poland
      • Bialystok, Poland, 15-351
        • Osteo Medic s.c. Artur Racewicz Jerzy Supronik
      • Bialystok, Poland, 15-404
        • SNZOZ Lege Artis
      • Elblag, Poland, 82-300
        • Centrum Kliniczno Badawcze
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House
      • Krakow, Poland, 30-688
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital w Krakowie
      • Lodz, Poland, 90-338
        • Centrum Terapii Wspolczesnej
      • Poznan, Poland, 61-251
        • Gaja Poradnie Lekarskie
      • Radom, Poland, 26-600
        • Centrum Medyczne "Diabetika"
      • Warszawa, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
      • Warszawa, Poland, 00-710
        • NBR Polska Tomasz Klodawski
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporow
      • Zabrze, Poland, 41-800
        • Prywatny Gabinet Janusz Gumprecht
    • Lubelski
      • Lublin, Lubelski, Poland, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
    • Lubuskie
      • Gorzow Wielkopolski, Lubuskie, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-481
        • Kresmed Sp. z o. o.
      • Bialystok, Podlaskie, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
    • Wielkopolskie Voivodeship
      • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Manati Ctr For Clin Research
  • Slovakia
      • Bardejov, Slovakia, 08501
        • DIADA s.r.o.
      • Hnusta, Slovakia, 98101
        • Diabetologicka ambulancia Diabetes care, s.r.o.
      • Kezmarok, Slovakia, 06001
        • Diabetologicka ambulancia DIAMO s.r.o.
      • Kralovsky Chlmec, Slovakia, 077 01
        • MOMED, s.r.o
      • Lucenec, Slovakia, 984 01
        • Diabetologicka ambulancia IN-DIA s.r.o.
      • Presov, Slovakia, 080 01
        • Diabetol s.r.o., Diabetologicka ambulancia
      • Rimavska Sobota, Slovakia, 979 01
        • OLIVER - MED s.r.o.
      • Sabinov, Slovakia, 08301
        • MEDI-DIA s.r.o.
      • Spisska Nova Ves, Slovakia, 052 01
        • Diabetologicka ambulancia MUDr. Gabriela Zimova
  • Slovenia
      • Celje, Slovenia, SI-3000
        • General Hospital Celje
      • Koper, Slovenia, SI-6000
        • Healthcare Centre Koper
      • Ljubljana, Slovenia, SI-1000
        • UKC Ljubljana, Endocrinology and Diabetes
      • Maribor, Slovenia, SI-2000
        • UKC Maribor - diabetes
      • Nova Gorica, Slovenia, SI-5000
        • Healtcare Centre Nova Gorica
  • Taiwan
      • Taichung City, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
  • United States
    • California
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Fresno, California, United States, 93720
        • Valley Research
      • La Mesa, California, United States, 91942
        • Velocity Clin Res San Diego
      • Lancaster, California, United States, 93534
        • First Valley Medical Group
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Los Angeles, California, United States, 90057
        • Velocity Clin Res Wstlke
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • Poway, California, United States, 92064
        • Gateway Research Center
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
      • West Hills, California, United States, 91304
        • San Fernando Valley Hlth Inst
    • Colorado
      • Colorado Springs, Colorado, United States, 80906
        • Optumcare Colorado Springs
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Northeast Research Institute
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Res Clin Miami Lakes
      • Ormond Beach, Florida, United States, 32174-6302
        • Complete Health Research
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Gillespie, Illinois, United States, 62033
        • Macoupin Research Group
      • Skokie, Illinois, United States, 60077
        • Evanston Premier Hlthcr Res
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Inst For Clin Res
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clin Research Ctr
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Brigham & Women's Hospital
      • Waltham, Massachusetts, United States, 02453
        • MassResearch, LLC
    • Michigan
      • Flint, Michigan, United States, 48504
        • Aa Mrc Llc
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare, PLC.
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Str Med Grp, PLLC
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Premier Research Inc.
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Mason, Ohio, United States, 45040
        • Albert J Weisbrot
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Corvallis Clinic PC Clinical Research Department
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians_Pittsburgh
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Holston Medical Group Pc
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research, Llc
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions
    • Texas
      • Arlington, Texas, United States, 76012-4637
        • Arlington Family Res. Ctr Inc
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • Houston, Texas, United States, 77074
        • Juno Research, LLC_Houston
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Plano, Texas, United States, 75093
        • Research Institute of Dallas
      • San Antonio, Texas, United States, 78230
        • VIP Trials
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • York Clinical Research LLC
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clin Res Ctr,LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Experimental: 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).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Active Comparator: 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).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in HbA1c (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68
Change From Week 12 in HbA1c (Week 52)
Time Frame: Week 12, 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.
Week 12, Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in FPG (Week 68)
Time Frame: Baseline (week 0), 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.
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 % 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.
At week 52
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
Time Frame: At 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.
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 % 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.
At week 52
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
Time Frame: At 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.
At week 68
Time to Event Analyses of Rescue Medication
Time Frame: Baseline (week 0), week 68
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.
Baseline (week 0), week 68
Change From Baseline in Body Weight (Week 68)
Time Frame: Baseline (week 0), 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.
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 (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.
Baseline (week 0), week 52
Percentage Change From Baseline in Body Weight (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68
Percentage Change From Week 12 in Body Weight (Week 52)
Time Frame: Week 12, 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.
Week 12, Week 52
Change From Baseline in Body Mass Index (BMI) (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in BMI (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68
Change From Baseline in Waist Circumference (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in Waist Circumference (Week 68)
Time Frame: Baseline (week 0), 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.
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 % 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.
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 >= 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.
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 % 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.
At week 52
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
Time Frame: At 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.
At week 68
Change From Baseline in Total Cholesterol (Week 52)
Time Frame: Baseline, 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.
Baseline, Week 52
Change From Baseline in Total Cholesterol (Week 68)
Time Frame: Baseline, 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.
Baseline, Week 68
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
Time Frame: Baseline, 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.
Baseline, Week 52
Change From Baseline in LDL (Week 68)
Time Frame: Baseline, 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.
Baseline, Week 68
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
Time Frame: Baseline, 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.
Baseline, Week 52
Change From Baseline in HDL (Week 68)
Time Frame: Baseline, 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.
Baseline, Week 68
Change From Baseline in Triglycerides (Week 52)
Time Frame: Baseline, 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.
Baseline, Week 52
Change From Baseline in Triglycerides (Week 68)
Time Frame: Baseline, 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.
Baseline, Week 68
Number of Adverse Events
Time Frame: From baseline (week 0) up to week 73
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.
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
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.
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 (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.
Baseline (week 0), week 52
Change From Baseline in Systolic Blood Pressure (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68
Change From Baseline in Diastolic Blood Pressure (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in Diastolic Blood Pressure (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68
Change From Baseline in Pulse (Week 52)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 52
Change From Baseline in Pulse (Week 68)
Time Frame: Baseline (week 0), 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.
Baseline (week 0), week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 8, 2023

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4635
  • U1111-1247-0210 (Other Identifier: World Health Organization (WHO))
  • 2020-000299-39 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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