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)
NCT ID: NCT06269107
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
485 participants
INTERVENTIONAL
2024-02-15
2025-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IcoSema
Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks.
IcoSema
IcoSema will be administered subcutaneously.
Insulin glargine
Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.
Insulin glargine
Insulin glargine will be administered subcutaneously.
Interventions
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IcoSema
IcoSema will be administered subcutaneously.
Insulin glargine
Insulin glargine will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T2D greater than or equal to (≥) 180 days before screening.
* HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole \[mmol/mol\]) as assessed by central laboratory on the day of screening.
* Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
* Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) at effective or maximum tolerated dose.
* Metformin
* Sulfonylureas
* Meglitinides (glinides)
* Dipeptidyl peptidase (DPP) 4 inhibitors
* Sodium glucose co transporter 2 inhibitors
* Alpha glucosidase inhibitors
* Thiazolidinediones
* Marketed oral combination products only including the products listed above.
* Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m\^2).
* Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
* Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
* Chronic heart failure classified as being in New York Heart Association Class IV at screening.
* Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.
Exclusion Criteria
* Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Scripps Whittier Diabetes Inst
La Jolla, California, United States
First Valley Med Grp Lancaster
Lancaster, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Clinical Trials Research_Sacramento
Sacramento, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Clinical Research of Cent FL
Winter Haven, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 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
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
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
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
Quality Research Inc
San Antonio, Texas, United States
Flourish Research
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 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
Kalamata, , Greece
Univ Gen Hospital Larisa
Larissa, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Mysore Medical College and Research Institute
Mysore, Karnataka, 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
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
ASL 4 Chiavarese
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
Tokyo, , Japan
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, Poland
SNZOZ Lege Artis
Bialystok, , Poland
Grazyna Pulka Specjalistyczny Osrodek "All-Med"
Krakow, , Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, , Poland
Centrum Terapii Współczesnej 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
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)
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Tekirdag Namık Kemal UTF
Tekirdağ, , Turkey (Türkiye)
Countries
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Other Identifiers
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U1111-1283-8648
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502484-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
NN1535-4988
Identifier Type: -
Identifier Source: org_study_id
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