A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide 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 semaglutide.
Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries.
Participants will get IcoSema or semaglutide, which they 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 18 clinic visits, 34 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.
Inclusion Criteria:
Exclusion Criteria:
Aparecida de Goiânia, Goiás 74935-530, Brazil
Nanjing, Jiangsu 210011, China
Shanghai, Shanghai Municipality 200040, China
Tianjin, Tianjin Municipality 300052, China
Tianjin, Tianjin Municipality 300070, China
Athens, GR-11526, Greece
Debrecen, Hajdú-Bihar H-4043, Hungary
Herzeliya, Israel 4630945, Israel
Chuo-ku, Tokyo, 103-0002, Japan
Fukuoka-shi, Fukuoka, 819-0006, Japan
Fukuoka-shi, Fukuoka, 819-0006, Japan
Sendai-shi, Miyagi, 983-0039, Japan
Moscow, 117292, Russia
Dnipro, 49038, Ukraine
Kyiv, 04053, Ukraine
Kyiv, 04114, Ukraine