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COMPLETED
NCT06269107
PHASE3

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)

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).

Official title: A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

485

Start Date

2024-02-15

Completion Date

2025-07-08

Last Updated

2026-05-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

IcoSema

IcoSema will be administered subcutaneously.

DRUG

Insulin glargine

Insulin glargine will be administered subcutaneously.

Locations (118)

Univ of Alabama_Birmingham

Birmingham, Alabama, United States

John Muir Physicians Network

Concord, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

First Valley Med Grp Lancaster

Lancaster, California, United States

Clinical Trials Research_Sacramento

Lincoln, California, United States

Desert Oasis Hlthcr Med Group

Palm Springs, California, United States

Desert Oasis Hlthcr Med Group

Palm Springs, California, United States

Northeast Research Institute

Fleming Island, Florida, United States

East Coast Institute For Research

Jacksonville, Florida, United States

Clinical Research of Cent FL

Winter Haven, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endo Res Solutions Inc

Roswell, Georgia, United States

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, United States

Elite Clinical Trials

Blackfoot, Idaho, United States

Cedar-Crosse Research Center

Chicago, Illinois, United States

Endeavor Health

Skokie, Illinois, United States

Cotton-O'Neil Diab & Endo Ctr

Topeka, Kansas, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

Endo and Metab Consultants

Rockville, Maryland, United States

Methodist Phys. Clinic

Omaha, Nebraska, United States

Albuquerque Clin Trials, Inc.

Albuquerque, New Mexico, United States

AMC Community Endocrinology

Albany, New York, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Physician's East Endocrinology

Greenville, North Carolina, United States

Diab & Endo Assoc of Stark Co

Canton, Ohio, United States

Advanced Medical Research

Maumee, Ohio, United States

New Venture Medical Research

Wadsworth, Ohio, United States

Essential Medical Research LLC

Tulsa, Oklahoma, United States

Holston Medical Group

Kingsport, Tennessee, United States

Amarillo Med Spec LLP

Amarillo, Texas, United States

Velocity Clinical Research- Cedar Park

Austin, Texas, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

North Texas Endocrine Center

Dallas, Texas, United States

Diabetes and Thyroid Ctr of FW

Fort Worth, Texas, United States

Fmc Science, Llc

Lampasas, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Quality Research Inc

San Antonio, Texas, United States

Flourish Research

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Simcare Medical Research, LLC

Sugar Land, Texas, United States

Wade Family Medicine

Bountiful, Utah, United States

TPMG Clinical Research

Newport News, Virginia, United States

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Huizhou Central People's Hospital-Endocrinology

Huizhou, Guangdong, China

Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

Hengshui, Hebei, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jinan Central Hospital

Jinan, Shandong, China

Shanghai Pudong New Area People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, China

Evangelismos Hospital

Athens, Greece

'G. Gennimatas' General Hospital of Athens

Athens, Greece

"Laiko" General Hospital of Athens

Athens, Greece

General Hospital of Kalamata - B Internal Medicine Department

Kalamata, Greece

Univ Gen Hospital Larisa

Larissa, Greece

"Thermi" Private Hosital

Thessaloniki, Greece

Ramaiah Memorial Hospital

Bangalore, Karnataka, India

Sai A Health Wellness LLP

Bangalore, Karnataka, India

Mysore Medical College and Research Institute

Mysore, Karnataka, India

CHL Hospitals

Indore, Madhya Pradesh, India

Goa Medical College

Goa, Maharashtra, India

BYL Nair Hospital and T N Medical College Department of endo

Mumbai, Maharashtra, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, India

BSES MG hospital

Mumbai, Maharashtra, India

Chellaram Diabetes Institute

Pune, Maharashtra, India

SMS Medical College & Hospital

Jaipur, Rajasthan, India

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, India

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, India

Udyaan Health Care

Lucknow, Uttar Pradesh, India

Post Graduate Institute of Medical Education & Research

Chandigarh, India

IPGME&R and SSKM Hospital

Kolkata, India

METTA Clinic (a unit of Healious Global Pvt. Ltd.)

Kolkata, India

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

L’Aquila, Abbruzzo, Italy

Casa Sollievo della Sofferenza reparto endocrinologia

San Giovanni Rotondo, FG, Italy

A.O.U. Policlinico Umberto I

Rome, Lazio, Italy

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

Ancona, Italy

Casa della Salute di Ceccano - Ambulatori Campus Biomedico

Ceccano (Frosinone), Italy

Polo Ospedaliero di Chiavari

Chiavari (genova), Italy

Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

Perugia, Italy

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan

Tokuyama clinic_Diabetic internal medicine

Chiba, Japan

Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine

Hokkaido, Japan

Oyama East Clinic_Internal Medicine

Tochigi, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Juntendo University Hospital_Diabetes, endocrinology and metabolism

Tokyo, Japan

NZOZ Przychodnia Specjalistyczna Medica

Lublin, Lubelski, Poland

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, Podlaskie Voivodeship, Poland

SNZOZ Lege Artis

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii

Gdansk, Poland

Care Clinic Sp. z o. o.

Katowice, Poland

Grazyna Pulka Specjalistyczny Osrodek "All-Med"

Krakow, Poland

Gabinet Lekarski Malgorzata Saryusz-Wolska

Lodz, Poland

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

Lodz, Poland

Velocity Nova Sp. z o.o.

Lublin, Poland

NBR Polska Tomasz Klodawski

Warsaw, Poland

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, Poland

Medical Concierge Centrum Medyczne

Warsaw, Poland

Clinhouse Centrum Medyczne

Zabrze, Poland

Velocity Nova Sp. z o.o.

Staszów, Świętokrzyskie Voivodeship, Poland

Advanced Clinical Research LLC

Bayamón, Puerto Rico

Dr R Dulabh

Johannesburg, Gauteng, South Africa

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Roodepoort Medicross Clinical Research Centre

Roodepoort, Gauteng, South Africa

Dr Pillay's Rooms

Durban, KwaZulu-Natal, South Africa

Clinical Research Institute of South Africa

KwaDukuza, KwaZulu-Natal, South Africa

Langeberg Clinical Trials

Cape Town, Western Cape, South Africa

Akdeniz University Tip Fakultesi Hastanesi

Antalya, Turkey (Türkiye)

Akdeniz Üniversitesi Hastanesi- Endokrinoloji

Antalya, Turkey (Türkiye)

Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji

Istanbul, Turkey (Türkiye)

İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

Istanbul, Turkey (Türkiye)

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Turkey (Türkiye)

T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye

Tekirdağ, Turkey (Türkiye)