CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 792 enrolled / 792 target
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Semaglutide 0.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04560998
NCT04560998Phase 3CompletedMonitor (11.5/mo)Completion was 24mo ago
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Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease

Novo Nordisk A/S·interventional·Posted Sep 23, 2020·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (semaglutide) for Diabetes Mellitus, Type 2 and Peripheral Arterial Disease. Completed, enrolled 792 participants across 283 sites in 21 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Peripheral Arterial Disease
CountriesAustria, Belgium, Canada, China, Czechia, Denmark, Germany, Greece, Hungary, India, Japan, Latvia, Malaysia, Norway, Poland, Russia, Spain, Sweden, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartOct 1, 2020
Primary CompletionJun 5, 2024
Study CompletionJul 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.8 years ago

Arms & Interventions

Semaglutideexperimental

Semaglutide given in addition to standard-of-care treatment

Drug: Semaglutide
Placebo (semaglutide)placebo_comparator

Placebo given in addition to standard-of-care treatment

Drug: Placebo (semaglutide)

Interventions

Semaglutidedrug

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.