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Effect of semaglutide on functional capacity in patients with type 2 diabetes and peripheral arterial disease(NN9535-4533) (STRIDE)

Effect of semaglutide on functional capacity in patients with type 2 diabetes and peripheral arterial disease (STRIDE)

792

Subjects included in FAS (792 subjects) had a mean age at baseline of 66.6 years, and 507 subjects (64.0%) were >=65 years of age. There were 480 (60.6%) patients who had >=10 years of diabetes history. Overall, 597 (75.4%) patients were male and 195 (24.6%) were female. The mean baseline body weight was 84.22 kg and mean baseline BMI was 29.55 kg/m2. In total, 203 (25.6%) of patients were current smokers and 367 (46.3%) of patients were previous smokers, with smoking being a risk factor for PAD. CV history at baseline included prior PAD (97.9%). Prior CV and PAD-related events at baseline included coronary revascularisation, myocardial infarction (MI), stroke, transient ischaemic attack, peripheral arterial revascularisation procedure and lower extremity amputation. The baseline median maximum walking distance and pain-free walking distance were 185.5 m and 114.5 m, respectively. The baseline geometric mean Ankle-Brachial Index (ABI) was 0.75 and baseline geometric mean Toe-Brachial Index (TBI) was 0.48. There were no apparent differences in demographics or baseline data between treatment groups.

A total of 1363 patients were screened for eligibility and 792 of whom were randomised (1:1) to treatment with semaglutide 1.0 mg (396 subjects) or placebo (396 subjects), and all 792 randomised subjects were included in full analysis set (FAS). Of these, 692 subjects (87.4%) (339 subjects with semaglutide 1.0 mg and 353 subjects with the placebo) completed the treatment of study drug.

More participants permanently discontinued trial product due to adverse events in the semaglutide 1.0 mg group versus placebo. This difference was mainly driven by non-serious GI adverse events. More participants reported events of cardiovascular disorders in the semaglutide 1.0 mg group versus placebo. However, no difference was observed in EAC-confirmed cardiovascular events between semaglutide 1.0 mg versus placebo. The safety profile of semaglutide s.c. 1.0 mg was similar to that observed in previous clinical studies with semaglutide. No unexpected findings were identified in the areas of interest evaluated.

Superiority of semaglutide 1.0 mg vs placebo was confirmed for change in maximum walking distance at week 52 -Treatment ratio of semaglutide 1 mg/placebo: 1.13; 95% CI [1.056; 1.211] Secondary Outcome Superiority of semaglutide 1.0 mg vs placebo was confirmed for change in maximum walking distance at week 57 -Treatment ratio of semaglutide 1.0 mg/placebo: 1.08; 95% CI [1.004; 1.156] Superiority of semaglutide 1.0 mg vs placebo was confirmed for change in VascuQoL-6 score at week 52 -Treatment difference of semaglutide 1.0 mg - placebo: 1.00; 95% CI [0.478; 1.518] Superiority of semaglutide 1.0 mg vs placebo was confirmed for change in pain-free walking distance at week 52 -Treatment ratio of semaglutide 1.0 mg/placebo: 1.11; 95% CI [1.033; 1.197]

STRIDE met its primary and key secondary objectives by demonstrating favourable effect of semaglutide s.c. 1.0 mg on both walking ability and Patient-reported symptoms and impacts of intermittent claudication (VascuQoL-6) compared to placebo. The study results support a favourable benefit-risk profile of semaglutide s.c. 1.0 mg in patients with T2D and PAD with intermittent claudication.

Mar. 29, 2025

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00509-4/abstract

No

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200141

Higo Yasumoto

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku

JPHC_clinical_trials@novonordisk.com

Higo Yasumoto

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku

+81-3-6266-1000

JPHC_clinical_trials@novonordisk.com

Complete

Oct. 01, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Male or female, age above or equal to 18 years at the time of informed consent (above or equal to 20 years for Japan)
-Diagnosed with type 2 diabetes
-Symptomatic PAD with intermittent claudication in Fontaine stage IIa

-Treatment with GLP-1receptor agonist or DPP4 inhibitor
-Walking ability limited by condition other than PAD
-Planned orthopaedic surgery or other major surgery
-Vascular revascularisation procedure 180 days prior to screening or planned

Both

Type 2 diabetes with PAD

Trial product: Semaglutide administered subcutaneously once-weekly
Trial product: Placebo administered subcutaneously once-weekly
Treatment period:52 weeks including 8-week dose escalation period

Treatment ratio of the median ratio to baseline at week 52 in maximum walking distance

+81-29-353-2800

Aug. 07, 2020

Austria/Belgium/Canada/China/Czech Republic/Denmark/Germany/Hungary/India/Japan/Malaysia/Norway/Poland/Spain/Sweden/Taiwan/United States