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

NCT04560998 · Completed

Last updated 2026-05-28

This study is testing whether a medicine called semaglutide improves walking ability in people who have both type 2 diabetes and peripheral arterial disease.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 792 people

Who can join Ages 18+ · all sexes

Timeline Started 2020-10 · est. completion 2024-07

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

What this study is testing ClinicalTrials.gov NCT04560998 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Drug

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.
Placebo (semaglutide) Drug

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.

Main thing measured	Change in Maximum Walking Distance on a Constant Load Treadmill Test
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2, Peripheral Arterial Disease
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04560998 ↗