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

What Was Tested

This registered phase 3 trial tested Semaglutide.

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.

It had two arms (groups): Semaglutide (experimental) and Placebo (semaglutide) (placebo comparator).

Semaglutide given in addition to standard-of-care treatment.

Placebo given in addition to standard-of-care treatment.

The registry classes the interventions as drug.

Who Took Part

The registry lists 792 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: current or previous treatment with any glp-1 receptor agonist (glp-1-ra) within 90 days prior to the day of screening; planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability); vascular revascularisation procedure of any kind 180 days prior to the day of screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-10-01 with completion listed for 2024-06-05.

It ran at 283 sites in United States (88), India (25), Russia (25), Canada (23), Japan (16) and Thailand (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Maximum Walking Distance on a Constant Load Treadmill Test (time frame: Baseline (week 0), end of treatment (week 52)).

It also tracked 15 secondary outcomes, for example Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test, Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score, Change in Pain-free Walking Distance on a Constant Load Treadmill Test, Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test, Change in Glycosylated Haemoglobin (HbA1c) and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 792 people.

With 792 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.