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

Conditions

• Diabetes Mellitus, Type 2
• Peripheral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Oct 1, 2020

Status verified

May 2026

Primary completion

Jun 5, 2024

Completion

Jul 12, 2024

Study Design

Enrollment

792 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide
  Semaglutide given in addition to standard-of-care treatment
• Placebo Comparator: Placebo (semaglutide)
  Placebo given in addition to standard-of-care treatment

Primary Outcome Measure

Change in Maximum Walking Distance on a Constant Load Treadmill Test [ Time Frame: Baseline (week 0), end of treatment (week 52) ]

Locations (88)

Related coverage on Hipa.ai

• Semaglutide Improves Walking Distance, Quality of Life in PAD with T2D
  Semaglutide · Jul 8, 2025 · ClinicalTrials.gov
• Semaglutide Phase 3 for PAD and T2D Improves Walking Distance and Quality of…
  Semaglutide · Jun 5, 2024 · ClinicalTrials.gov

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