BENITIONSClinical Trial Intelligence

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)

3상 완료 NCT05259033

대상 질환Diabetes Mellitus, Type 2
임상 단계3상
스폰서Novo Nordisk A/S
상태완료
참여자 수683 명
중재(약물)IcoSema, Semaglutide 1 mg
시작일2022년 4월 11일
완료일2023년 12월 13일
결과 공개일2025년 1월 17일

요약

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.

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Baseline (week 0), (week 52) · Percentage point of HbA1c

IcoSema-1.40 ± 0.91 Percentage point of HbA1c
Semaglutide-0.86 ± 0.96 Percentage point of HbA1c
p-value<0.0001
Estimated treatment difference-0.44 (95% CI -0.56–-0.33)

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