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
| Semaglutide | 1.21 Ratio of maximum walking distance |
|---|
| Placebo | 1.08 Ratio of maximum walking distance |
|---|
| p-value | 0.0004 |
| The Hodges-Lehmann estimate | 1.13 (95% CI 1.056–1.211) |
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。