A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripher… (NCT04560998) | Clinical Trial Compass
CompletedPhase 3
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
United States, Austria, Belgium792 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.
. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — has the data been published yet, and if so, what did the results show about whether semaglutide actually improved how far people with PAD and type 2 diabetes could walk on a treadmill?
2Since this was a Phase 3 trial comparing semaglutide directly against a placebo, what does my doctor think the results might mean for whether semaglutide could become a standard treatment option for someone in my situation with both PAD and type 2 diabetes?
3I already have type 2 diabetes and may be on medications like metformin or other diabetes drugs — would adding or switching to semaglutide based on what this trial was studying make sense for me, or is my current treatment plan already addressing both my blood sugar and my leg circulation issues?
4The trial measured maximum walking distance on a treadmill test as its main goal — is my walking ability or leg pain already being formally tracked in my care, and should it be, so we can tell whether any treatment is actually helping over time?
5Are there already approved treatments or other completed studies I should know about for managing PAD alongside type 2 diabetes, in case the results from this semaglutide trial don't change my doctor's current recommendations for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Maximum Walking Distance on a Constant Load Treadmill Test
Timeframe: Baseline (week 0), end of treatment (week 52)