BENITIONSClinical Trial Intelligence

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

3期 已完成 NCT04560998

适应症Diabetes Mellitus, Type 2, Peripheral Arterial Disease
分期3期
申办方Novo Nordisk A/S
状态已完成
受试者人数792 人
干预(药物)Semaglutide, Placebo (semaglutide)
开始日期2020年10月1日
完成日期2024年6月5日
结果公布日2025年7月8日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。