NCT04560998

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

Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
DRUG	Placebo (semaglutide)	Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-06-05
• Completion: 2024-07-12
• First posted: 2020-09-23
• Last updated: 2025-12-12
• Results posted: 2025-07-08

Locations

194 sites across 21 countries: United States, Austria, Belgium, Canada, China, Czechia, Denmark, Germany, Greece, Hungary, India, Japan, Latvia, Malaysia, Norway, Poland, Russia, Spain, Sweden, Taiwan, Thailand

Regulatory

• FDA-regulated drug study