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

Diabetes Mellitus, Type 2 Clinical Trial

— PIONEER PLUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707469
• Other study ID #: NN9924-4635
• Secondary ID: U1111-1247-02102
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2021
• Est. completion date: March 8, 2023

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1606
• Est. completion date: March 8, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Australia	Barwon Health (The Geelong Hospital)	Geelong	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	South Australian Endocrine Research	Keswick	South Australia
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Core Research Centre	Milton	Queensland
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Bulgaria	"MHAT-Blagoevgrad", Department of Internal Diseases	Blagoevgrad
Bulgaria	Medical Center Zdrave Lom	Lom
Bulgaria	"MHAT - Pazardzhik"	Pazardzhik
Bulgaria	UMHAT Pulmed, Department of endocrinology	Pazardzhik
Bulgaria	OCSOMCE - Dr. Albena Dinkova EOOD	Pleven
Bulgaria	'MHAT Sveta Karidad' EAD	Plovdiv
Bulgaria	UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases	Plovdiv
Bulgaria	'MHAT Hadzhi Dimitar' OOD	Sliven
Bulgaria	"Medical center Smolyan clinical research" OOD	Smolyan
Bulgaria	Medical Institute of Ministry of interior	Sofia
Bulgaria	UMHAT "Aleksandrovska"	Sofia
Bulgaria	USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology	Sofia
Bulgaria	AIPSMC Dr. Artin Magardichyan EOOD	Varna
Bulgaria	UMHAT Sveta Marina EAD	Varna
Bulgaria	MHAT- Hristo Botev	Vratsa
Bulgaria	"MHAT "Sveti Panteleimon" - Yambol" AD	Yambol
Canada	LMC ClinRsrh Inc.Brampton	Brampton	Ontario
Canada	C-endo Diab Endo Clin Calgery	Calgary	Alberta
Canada	LMC Clin Res Inc. Calgary	Calgary	Alberta
Canada	LMC (Thornhill)	Concord	Ontario
Canada	LMC Endo Ctr (Etobicoke) Ltd	Etobicoke	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Applied Med Inf Res	Montreal	Quebec
Canada	LMC Research Inc. Ottawa	Nepean	Ontario
Canada	LMC Oakville	Oakville	Ontario
Canada	LMC Clin Rsrch Inc. (Montreal)	Saint-Laurent	Quebec
Canada	Winterberry Family Medicine	Stoney Creek	Ontario
Canada	LMC Endo Centres Ltd.(Bayview)	Toronto	Ontario
Croatia	Klinicki bolnicki centar Osijek	Osijek
Croatia	KBC Rijeka, Endokrinologija	Rijeka	Primorsko - Goranska Županija
Croatia	Opca bolnica Dr. Josip Bencevic	Slavonski Brod
Croatia	KB Dubrava, Zavod za endokrinologiju i dijabetes	Zagreb
Croatia	Klinicka bolnica Sveti Duh	Zagreb
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Czechia	Ordinace pro choroby srdce	Chomutov
Czechia	Diahaza s.r.o.	Holešov
Czechia	DIALINE s.r.o.	Plzen 3
Czechia	Diabetologická a endokrinologická ambulance Praha	Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Estonia	Private Endocrnologist Dr Viitas	Pärnu
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	Estonian Diabetes Centre	Tallinn
Estonia	Merelahe Family Doctors Centre	Tallinn
Estonia	Tartu University Hospital Internal Medicine Clinic	Tartu
Germany	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	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
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	Óbudai Egészségügyi Centrum	Budapest
Hungary	Szocs Depot Egészségügyi Szolgáltató Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika	Debrecen
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület	Debrecen
Hungary	Selye János Kórház és Rendelointézet	Komárom	Komárom-Esztergom
Hungary	PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum	Pécs
Hungary	Fejér Megyei Szent György Oktatókórház	Székesfehérvár
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
India	KLES & Prabhakar Kore Hospital and Research Centre	Belgaum	Karnatka
India	Apollo Hospital	Delhi	New Delhi
India	Endolife Specialty Hospitals	Guntur	Andhra Pradesh
India	Care Outpatient Centre	Hyderabad	Andhra Pradesh
India	Gandhi Hospital & Medical college	Hyderabad	Telengana
India	Gleneagles Global Hospitals	Hyderabad	Telengana
India	Osmania General Hospital	Hyderabad	A.p.
India	Amrita Institute Of Medical Sciences & Research Centre	Kochi	Kerala
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	I.P.G.M.E & R Hospital	Kolkata	West Bengal
India	MV Hospital and Research Centre	Lucknow	Uttar Pradesh
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Seth GS medical college and KEM Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Dehli	New Delhi
India	Fortis Hospital, Shalimar Bagh, New Delhi	New Delhi	Delhi
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
India	Inamdar Multispeciality Hospital	Pune	Maharashtra
India	PGIMS Rohtak	Rohtak	Haryana
India	Nirmal Hospital Pvt. Ltd.	Surat	Gujarat
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska	Bialystok	Podlaskie
Poland	Osteo Medic s.c. Artur Racewicz Jerzy Supronik	Bialystok
Poland	SNZOZ Lege Artis	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie Voivodeship
Poland	Centrum Kliniczno Badawcze	Elblag
Poland	Centrum Badan Klinicznych PI-House	Gdansk
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski	Lubuskie
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital w Krakowie	Krakow
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	NZOZ Przychodnia Specjalistyczna Medica	Lublin	Lubelski
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Poland	Gaja Poradnie Lekarskie	Poznan
Poland	Centrum Medyczne "Diabetika"	Radom
Poland	NBR Polska Tomasz Klodawski	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Prywatny Gabinet Janusz Gumprecht	Zabrze
Puerto Rico	Manati Ctr For Clin Research	Manati
Slovakia	DIADA s.r.o.	Bardejov
Slovakia	Diabetologicka ambulancia Diabetes care, s.r.o.	Hnusta
Slovakia	Diabetologicka ambulancia DIAMO s.r.o.	Kezmarok
Slovakia	MOMED, s.r.o	Kralovsky Chlmec
Slovakia	Diabetologicka ambulancia IN-DIA s.r.o.	Lucenec
Slovakia	Diabetol s.r.o., Diabetologicka ambulancia	Presov
Slovakia	OLIVER - MED s.r.o.	Rimavska Sobota
Slovakia	MEDI-DIA s.r.o.	Sabinov
Slovakia	Diabetologicka ambulancia MUDr. Gabriela Zimova	Spisska Nova Ves
Slovenia	General Hospital Celje	Celje
Slovenia	Healthcare Centre Koper	Koper
Slovenia	UKC Ljubljana, Endocrinology and Diabetes	Ljubljana
Slovenia	UKC Maribor - diabetes	Maribor
Slovenia	Healtcare Centre Nova Gorica	Nova Gorica
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Holston Medical Group Pc	Bristol	Tennessee
United States	American Clinical Trials	Buena Park	California
United States	Mercury Str Med Grp, PLLC	Butte	Montana
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Optumcare Colorado Springs	Colorado Springs	Colorado
United States	Corvallis Clinic PC Clinical Research Department	Corvallis	Oregon
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Velocity Clinical Research, Dallas	Dallas	Texas
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Aa Mrc Llc	Flint	Michigan
United States	Prestige Clinical Research	Franklin	Ohio
United States	Valley Research	Fresno	California
United States	Macoupin Research Group	Gillespie	Illinois
United States	East West Med Res Inst	Honolulu	Hawaii
United States	Juno Research, LLC_Houston	Houston	Texas
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Northeast Research Institute	Jacksonville	Florida
United States	Velocity Clin Res San Diego	La Mesa	California
United States	First Valley Medical Group	Lancaster	California
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Pacific Clinical Studies	Los Alamitos	California
United States	Velocity Clin Res Wstlke	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Albert J Weisbrot	Mason	Ohio
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	San Marcus Res Clin Miami Lakes	Miami Lakes	Florida
United States	York Clinical Research LLC	Norfolk	Virginia
United States	Intend Research	Norman	Oklahoma
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	Complete Health Research	Ormond Beach	Florida
United States	MD Medical Research	Oxon Hill	Maryland
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Preferred Primary Care Physicians_Pittsburgh	Pittsburgh	Pennsylvania
United States	Research Institute Of Dallas	Plano	Texas
United States	Gateway Research Center	Poway	California
United States	Dominion Medical Associates	Richmond	Virginia
United States	Endo Res Solutions Inc	Roswell	Georgia
United States	VIP Trials	San Antonio	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	Encompass Clinical Research_Spring Valley	Spring Valley	California
United States	Cotton O'Neil Clin Research Ctr	Topeka	Kansas
United States	Premier Research Inc.	Trenton	New Jersey
United States	Arcturus Healthcare, PLC.	Troy	Michigan
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	MassResearch, LLC	Waltham	Massachusetts
United States	Chase Medical Research LLC	Waterbury	Connecticut
United States	Iowa Diab & Endo Res Center	West Des Moines	Iowa
United States	San Fernando Valley Hlth Inst	West Hills	California
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  Germany,  Hungary,  India,  Poland,  Puerto Rico,  Slovakia,  Slovenia,  Taiwan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Week 12, Week 52
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	At week 52
Secondary	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.	At week 68
Secondary	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.	At week 52
Secondary	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.	At week 68
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Week 12, Week 52
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	At week 52
Secondary	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.	At week 68
Secondary	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.	At week 52
Secondary	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.	At week 68
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 68
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 68
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 68
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 68
Secondary	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.	From baseline (week 0) up to week 73
Secondary	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.	From baseline (week 0) up to week 68
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68
Secondary	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.	Baseline (week 0), week 52
Secondary	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.	Baseline (week 0), week 68