A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
3상
완료
NCT04560998
| 대상 질환 | Diabetes Mellitus, Type 2, Peripheral Arterial Disease |
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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 | 792 명 |
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| 중재(약물) | Semaglutide, Placebo (semaglutide) |
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| 시작일 | 2020년 10월 1일 |
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| 완료일 | 2024년 6월 5일 |
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| 결과 공개일 | 2025년 7월 8일 |
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요약
This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Change in Maximum Walking Distance on a Constant Load Treadmill Test
Baseline (week 0), end of treatment (week 52) · Ratio of maximum walking distance
| Semaglutide | 1.21 Ratio of maximum walking distance |
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| Placebo | 1.08 Ratio of maximum walking distance |
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| p-value | 0.0004 |
| The Hodges-Lehmann estimate | 1.13 (95% CI 1.056–1.211) |
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