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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
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
IcoSema
IcoSema will be administered subcutaneously.
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)