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Semaglutide for Peripheral Arterial Disease in Type 2 Diabetes (STRIDE Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:
Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (week -2) to end of treatment (week 52)
Awards & highlights

STRIDE Trial Summary

This trial is testing if semaglutide can improve walking ability in patients with PAD and type 2 diabetes.

Who is the study for?
This trial is for adults with type 2 diabetes and peripheral arterial disease (PAD) who can walk more than 200 meters without stopping but not over 600 meters. They must have a low ankle-brachial-index or toe-brachial index, indicating PAD severity. Excluded are those with recent major cardiovascular events, heart failure NYHA class III-IV, walking limitations due to other conditions, prior GLP-1 receptor agonist treatment within 90 days, or planned surgeries affecting walking.Check my eligibility
What is being tested?
The study tests if semaglutide improves walking ability in people with PAD and type 2 diabetes compared to a placebo. Participants will be randomly assigned to receive either semaglutide or a dummy medicine weekly by injection for about 59 weeks. The study includes treadmill tests and regular clinic visits to monitor progress.See study design
What are the potential side effects?
While the specific side effects of semaglutide in this trial context aren't listed, common ones from its use as a diabetes medication include digestive issues like nausea and diarrhea, potential risk of low blood sugar when combined with other medications, and possible inflammation of the pancreas.

STRIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have leg pain when walking that goes away with rest.
Select...
I am at least 18 years old, or 20 if I am in Japan.
Select...
My blood flow in legs is low, shown by ABI or TBI tests.
Select...
I have leg pain when walking that goes away with rest.

STRIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (week -2) to end of treatment (week 52)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (week -2) to end of treatment (week 52) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in maximum walking distance on a constant load treadmill test
Secondary outcome measures
Change in High density lipoprotein (HDL)- cholesterol
Change in Low-density lipoprotein (LDL)- cholesterol
Change in Short Form 36 (SF-36) physical functioning domain
+12 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

STRIDE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide given in addition to standard-of-care treatment
Group II: Placebo (semaglutide)Placebo Group1 Intervention
Placebo given in addition to standard-of-care treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,237 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
10 Patients Enrolled for Peripheral Arterial Disease
Clinical Transparency (1452)Study DirectorNovo Nordisk A/S
7 Previous Clinical Trials
602,235 Total Patients Enrolled

Media Library

Placebo (semaglutide) Clinical Trial Eligibility Overview. Trial Name: NCT04560998 — Phase 3
Peripheral Arterial Disease Research Study Groups: Placebo (semaglutide), Semaglutide
Peripheral Arterial Disease Clinical Trial 2023: Placebo (semaglutide) Highlights & Side Effects. Trial Name: NCT04560998 — Phase 3
Placebo (semaglutide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04560998 — Phase 3
Peripheral Arterial Disease Patient Testimony for trial: Trial Name: NCT04560998 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has been done that is similar to this Semaglutide study?

"At this moment, there are a total of 58 studies being conducted that involve Semaglutide. Out of these, 27 are in Phase 3. Furthermore, while many of the studies are based in Loma Linda, California, there are 3702 locations where these studies are taking place."

Answered by AI

What are the primary conditions that Semaglutide has been proven to ameliorate?

"Semaglutide can help manage chronic weight and also be used in conjunction with a reduced-calorie diet, exercise, to treat one or more weight-related comorbid conditions."

Answered by AI

Can patients sign up to participate in this research project at this time?

"Yes, the clinical trial is open and presently looking for participants, with 43 different locations admitting 800 patients in total. The study was originally posted on October 1st, 2020 and was last edited on March 29th, 2022."

Answered by AI

Have there been any reports of negative side effects from Semaglutide?

"Based on our observations, Semaglutide's safety is comparable to other Phase 3 drugs; it falls in the middle of the 1 to 3 scale."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Georgia
Maryland
Other
How old are they?
18 - 65
65+
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

to help myself and others. I thought the clinical site was in Covington, LA.
PatientReceived 2+ prior treatments
I need to lose wait and I am hoping this might help. I'd love to contribute to anything that could help with this condition.
PatientReceived 2+ prior treatments
I am interested as my feet are starting to bother me and I have never trid medicine for this before.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
2020. "A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04560998.
All > Diabetes Type 2 > Pad
~18 spots leftby Jun 2024
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