BENITIONSClinical Trial Intelligence

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 질환Diabetes Mellitus, Type 2, Peripheral Arterial Disease
임상 단계3상
스폰서Novo Nordisk A/S
상태완료
참여자 수792 명
중재(약물)Semaglutide, Placebo (semaglutide)
시작일2020년 10월 1일
완료일2024년 6월 5일
결과 공개일2025년 7월 8일

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

Semaglutide1.21 Ratio of maximum walking distance
Placebo1.08 Ratio of maximum walking distance
p-value0.0004
The Hodges-Lehmann estimate1.13 (95% CI 1.056–1.211)

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