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
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
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).
Inclusion Criteria:
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.
Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m^2).
Exclusion Criteria:
Beijing, Beijing Municipality 100050, China
Hengshui, Hebei 053000, China
Shanghai, Shanghai Municipality 201200, China
Goa, Maharashtra 403 202, India
L’Aquila, Abbruzzo 67100, Italy
Hokkaido, 060-0001, Japan
Bialystok, Podlaskie Voivodeship 15-435, Poland
Istanbul, 34371, Turkey (Türkiye)
Istanbul, 34390, Turkey (Türkiye)