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)
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT06269107
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 474
-
Male or female and age above or equal to 18 years at the time of signing the informed consent.
-
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).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbaring potential and not using highly effective contraceptive method.
- 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).
- Any episodes of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IcoSema IcoSema Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks. Insulin glargine Insulin glargine Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c) From baseline (week 0) to week 40 Measured in percentage (%)-point.
- Secondary Outcome Measures
Name Time Method Time spent greater than (>) 10.0 mmol/L (180 mg/dL) From week 36 to week 40 Measured in % of readings.
Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) From week 36 to week 40 Measured in % of readings.
Change in body weight From baseline (week 0) to week 40 Measured in kilogram (kg).
Time spent less than (<) 3.0 mmol/L (54 mg/dL) From week 36 to week 40 Measured in % of readings.
Weekly basal insulin dose From week 38 to week 40 Measured in units of insulin.
Change in fasting plasma glucose (FPG) From baseline (week 0) to week 40 Measured in mmol/l.
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) From baseline (week 0) to week 45 Measured in number of episodes.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction From baseline (week 0) to week 40 The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication.
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) From baseline (week 0) to week 45 Measured in number of episodes.
Number of severe hypoglycaemic episodes (level 3) From baseline (week 0) to week 45 Measured in number of episodes.
Trial Locations
- Locations (89)
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, 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.
🇵🇱Staszow, Świętokrzyskie, Poland
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
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
Albany Medical College - Div of 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, China
Beijing Friendship Hospital, Capital Medical University-Endocrinology
🇨🇳Beijing, Beijing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, 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
🇨🇳Jinan, Shandong, China
Shanghai Pudong New Area People's Hospital-Endocrinology
🇨🇳Shanghai, Shanghai, 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, Endocrinology & Metabolic Disease
🇬🇷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
Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia
🇮🇹L'Aquila, Abbruzzo, Italy
Casa Sollievo della Sofferenza reparto endocrinologia
🇮🇹San Giovanni Rotondo, FG, Italy
I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani
🇮🇹Ancona, Italy
Casa della Salute di Ceccano (FR)
🇮🇹Ceccano (Frosinone), Italy
ASL 4 Chiavarese
🇮🇹Chiavari (genova), Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
🇮🇹Perugia, Italy
A.O.U. Policlinico Umberto I
🇮🇹Rome, Italy
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Tokuyama clinic
🇯🇵Chiba, Japan
Oodouri Diabetes, Internal medicine Clinic
🇯🇵Hokkaido, Japan
Oyama East Clinic
🇯🇵Tochigi, Japan
NBR Polska Tomasz Klodawski
🇵🇱Warszawa, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
🇵🇱Warszawa, Poland
Clinhouse Centrum Medyczne
🇵🇱Zabrze, Poland
Advanced Clinical Research LLC
🇵🇷Bayamon, 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
Clinical Research Institute of South Africa
🇿🇦KwaDukuza, KwaZulu Natal, South Africa
Dr Pillay's Rooms
🇿🇦Durban, KwaZulu-Natal, South Africa
Langeberg Clinical Trials
🇿🇦Cape Town, Western Cape, South Africa
Akdeniz University Tip Fakultesi Hastanesi
🇹🇷Antalya, Turkey
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Tekirdag Namık Kemal UTF
🇹🇷Tekirdag, Turkey