A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week 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 icodec.
Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe.
Participants will get IcoSema or insulin icodec, which participants must inject once a week 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 have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.
Key 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% (53.0 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 for 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 for 90 days or more before screening:
Body mass index (BMI) below or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation.
Key exclusion criteria
North Massapequa, New York 11758-1802, United States
Wollongong, New South Wales 2500, Australia
Hengshui, Hebei 053000, China
Nanjing, Jiangsu 210011, China
Tianjin, Tianjin Municipality 300052, China
Secunderabad, Andhra Pradesh 500003, India
Thriruvananthapuram, Kerala 695 032, India
Chandigarh, Punjab 160012, India
Koriyama-shi, Fukushima, Japan 963-8851, Japan
Chigasaki-shi, Kanagawa, Japan 253-0044, Japan
Chiba-shi, Chiba, 260-0804, Japan
Fukuoka-shi, Fukuoka, 819-0006, Japan
Fukuoka-shi, Fukuoka, 819-0006, Japan
Fukuoka-shi, Fukuoka, 819-0168, Japan
Hokkaido, 062-0007, Japan
Saga-shi, Saga, 840-0937, Japan
Yokohama-shi, Kanagawa, 236-0004, Japan
Lørenskog, 1478, Norway
Senhora Da Hora, Matosinhos, Matosinhos 4464-513, Portugal
Amadora, 2720-276, Portugal
Bucharest, Bucurestii 020475, Romania
Bucheon-si, Gyeonggi-do 14647, South Korea
Ankara, Altindag 06230, Turkey (Türkiye)