A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

May 27, 2025

Study Completion Date

July 8, 2025

Conditions
Type 2 Diabetes
Interventions
DRUG

IcoSema

IcoSema will be administered subcutaneously.

DRUG

Insulin glargine

Insulin glargine will be administered subcutaneously.

Trial Locations (92)

1724

Roodepoort Medicross Clinical Research Centre, Roodepoort

1812

Dr R Dulabh, Johannesburg

2001

Newtown Clinical Research, Johannesburg

4449

Clinical Research Institute of South Africa, KwaDukuza

4450

Dr Pillay's Rooms, Durban

7572

Langeberg Clinical Trials, Cape Town

10676

Evangelismos Hospital, Athens

11527

"Laiko General Hospital of Athens", Athens

12203

AMC Community Endocrinology, Albany

14224

Southgate Medical Group, LLP, West Seneca

16043

ASL 4 Chiavarese, Chiavari (genova)

20162

Grande Ospedale Metropolitano Niguarda, Milan

23606

TPMG Clinical Research, Newport News

24100

General Hospital of Kalamata, Kalamata

27834

Physician's East Endocrinology, Greenville

30318

Atlanta Diabetes Associates, Atlanta

32003

Northeast Research Institute, Fleming Island

33880

Clinical Research of Cent FL, Winter Haven

34371

Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul

34899

T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi, Istanbul

41110

Univ Gen Hospital Larisa, Larissa

43537

Advanced Medical Research, Maumee

44718

Diab & Endo Assoc of Stark Co, Canton

57001

"Thermi Private Hosital", Thessaloniki

59030

Tekirdag Namık Kemal UTF, Tekirdağ

60077

Endeavor Health, Skokie

60127

I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani, Ancona

60607

Cedar-Crosse Research Center, Chicago

66606

Cotton-O'Neil Diab & Endo Ctr, Topeka

67100

ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia, L’Aquila

68114

Methodist Phys. Clinic, Omaha

71013

Casa Sollievo della Sofferenza reparto endocrinologia, San Giovanni Rotondo

75230

Velocity Clinical Res-Dallas, Dallas

75231

North Texas Endocrine Center, Dallas

76132

Diabetes and Thyroid Ctr of FW, Fort Worth

76550

Fmc Science, Llc, Lampasas

78209

Quality Research Inc, San Antonio

78229

Flourish Research, San Antonio

78231

Consano Clinical Research, LLC, Shavano Park

78759

Velocity Clinical Research- Cedar Park, Austin

79106

Amarillo Med Spec LLP, Amarillo

83221

Elite Clinical Trials, Blackfoot

87102

Albuquerque Clin Trials, Inc., Albuquerque

91355

Desert Oasis Hlthcr Med Group, Palm Springs

92037

Scripps Whittier Diabetes Inst, La Jolla

92262

Desert Oasis Hlthcr Med Group, Palm Springs

93534

First Valley Med Grp Lancaster, Lancaster

95821

Clinical Trials Research_Sacramento, Sacramento

100044

Peking University People's Hospital-Endocrinology, Beijing

100050

Beijing Friendship Hospital, Capital Medical University-Endocrinology, Beijing

160012

Post Graduate Institute of Medical Education & Research, Chandigarh

201200

Shanghai Pudong New Area People's Hospital-Endocrinology, Shanghai

210011

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

212001

The Affiliated Hospital of Jiangsu University, Zhenjiang

226002

Udyaan Health Care, Lucknow

250013

Jinan Central Hospital Affiliated to Shandong University, Jinan

Jinan Central Hospital, Jinan

302004

SMS Medical College & Hospital, Jaipur

302006

Diabetes, Thyroid and Endocrine Centre, Jaipur

400008

BYL Nair Hospital and T N Medical College Department of endo, Mumbai

400012

Seth GS Medical College & KEM Hospital, Mumbai

400058

BSES MG hospital, Mumbai

404000

Chongqing University Three Gorges Hospital, Chongqing

411021

Chellaram Diabetes Institute, Pune

516001

Huizhou Central People's Hospital-Endocrinology, Huizhou

560054

Ramaiah Memorial Hospital, Bangalore

570001

Mysore Medical College and Research Institute, Mysore

600086

Madras Diabetes Research Foundation, Chennai

44281-9236

New Venture Medical Research, Wadsworth

115 27

'G. Gennimatas' General Hospital of Athens, Athens

00161

A.O.U. Policlinico Umberto I, Rome

03023

Casa della Salute di Ceccano - Ambulatori Campus Biomedico, Ceccano (Frosinone)

06129

Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia, Perugia

880-0034

Heiwadai Hospital_Internal Medicine, Miyazaki

261-0004

Tokuyama clinic_Diabetic internal medicine, Chiba

060-0001

Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine, Hokkaido

323-0022

Oyama East Clinic_Internal Medicine, Tochigi

103-0027

Tokyo-Eki Center-building Clinic_Internal Medicine, Tokyo

104-0031

Fukuwa Clinic_Internal Medicine, Tokyo

113-8431

Juntendo University Hospital, Tokyo

15-435

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok

15-404

SNZOZ Lege Artis, Bialystok

30-033

"Grazyna Pulka Specjalistyczny Osrodek All-Med", Krakow

90-132

Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz

90-338

Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz

20-362

Velocity Nova Sp. z o.o., Lublin

00-710

NBR Polska Tomasz Klodawski, Warsaw

02-507

PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warsaw

41-807

Clinhouse Centrum Medyczne, Zabrze

28-200

Velocity Nova Sp. z o.o., Staszów

00959

Advanced Clinical Research LLC, Bayamón

07058

Akdeniz University Tip Fakultesi Hastanesi, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY