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 질환 | Diabetes Mellitus, Type 2 |
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| 임상 단계 | 3상 |
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| 스폰서 | Novo Nordisk A/S |
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| 상태 | 완료 |
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| 참여자 수 | 683 명 |
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| 중재(약물) | IcoSema, Semaglutide 1 mg |
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| 시작일 | 2022년 4월 11일 |
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| 완료일 | 2023년 12월 13일 |
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| 결과 공개일 | 2025년 1월 17일 |
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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 |
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| Semaglutide | -0.86 ± 0.96 Percentage point of HbA1c |
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| p-value | <0.0001 |
| Estimated treatment difference | -0.44 (95% CI -0.56–-0.33) |
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