A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2) (COMBINE 2)
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|ClinicalTrials.gov Identifier: NCT05259033|
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : November 4, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: IcoSema Drug: Semaglutide 1 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||680 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 11, 2022|
|Estimated Primary Completion Date :||January 12, 2024|
|Estimated Study Completion Date :||February 17, 2024|
Participants will get once weekly dose
IcoSema once weekly subcutaneously (s.c., under the skin) using a needle and a pen.
For about 1 year and 1 month.
Participants will get once weekly dose
Drug: Semaglutide 1 mg
Semaglutide once weekly subcutaneously (s.c., under the skin). Dose titrated to 1mg over 8 weeks (0.25 mg for 4 weeks, 0.5 mg for 4 weeks). For about 1 year and 1 month.
- Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline week 0 (V2) to week 52 (V54) ]Percentage-point
- Change in fasting plasma glucose (FPG) [ Time Frame: From baseline week 0 (V2) to week 52 (V54) ]Measured in mmol/L
- Change in body weight [ Time Frame: From baseline week 0 (V2) to week 52 (V54) ]Measured in Kg
- Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline week 0 (V2) to week 57 (V56) ]Number of episodes
- Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [ Time Frame: From baseline week 0 (V2) to week 57 (V56) ]Number of episodes
- Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline week 0 (V2) to week 57 (V56) ]Number of episodes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05259033
|Contact: Novo Nordisk||(+1) email@example.com|
|Study Director:||Clinical Transparency (dept. 1452)||Novo Nordisk A/S|