A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.
Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Inclusion Criteria:
Male or female and age above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening:
Body mass index (BMI) less than or equal to 40.0 kg/m^2.
Exclusion Criteria:
North Massapequa, New York 11758-1802, United States
Saint Ingbert-Oberwürzbach, 66386, Germany
Chandigarh, Punjab 160012, India
Kawagoe-shi, Saitama, Japan 350-0851, Japan
Shinjuku-ku, Tokyo 1600023, Japan
Chiba-shi, Chiba, 260-0804, Japan
Chuo-ku, Tokyo, 103-0002, Japan
Chuo-ku, Tokyo, 103-0002, Japan
Mito-shi, Ibaraki, 311-4153, Japan
Cheras, Kuala Lumpur 56000, Malaysia
Cheras, Kuala Lumpur 56000, Malaysia
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Ampang, Selangor 68000, Malaysia
Bialystok, Podlaskie Voivodeship 15-435, Poland
Chiang Mai, Mueang Chiang Mai District 50200, Thailand
Adana, 01250, Turkey (Türkiye)