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

JRCT ID: jRCT2031200141

Registered date:09/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes with PAD
• Date of first enrollment: 01/10/2020
• Target sample size: 800
• Countries of recruitment: Austria,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Germany,Japan,Hungary,Japan,India,Japan,Malaysia,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Treatment ratio of the median ratio to baseline at week 52 in maximum walking distance

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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

Exclude criteria

-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

Related Information

• Primary Sponsor: Higo Yasumoto
• Secondary ID(s): NCT04560998,2019-003399-38