A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
Phase 3
Completed
NCT04560998
| Condition | Diabetes Mellitus, Type 2, Peripheral Arterial Disease |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Novo Nordisk A/S |
|---|
| Status | Completed |
|---|
| Enrollment | 792 participants |
|---|
| Interventions | Semaglutide, Placebo (semaglutide) |
|---|
| Start date | Oct 1, 2020 |
|---|
| Completion date | Jun 5, 2024 |
|---|
| Results posted | Jul 8, 2025 |
|---|
Summary
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) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.