A research study to compare a medicine called semaglutide against placebo in people with peripheral arterial disease and type 2 diabetes

Phase 1

• Conditions: Peripheral arterial diseaseDiabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-003399-38-BE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-17
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

- Male or female, age above or equal to 18 years at the time of signing informed consent.
For Japan and Taiwan: Male or female, age above or equal to 20 years at the time of signing informed consent.
- 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:
a. 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.
b. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of equal to or above 200 meters/656 feet.
c. 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 below 600 meters/1968 feet.
d. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.70 (the leg with lowest index is chosen in case of bilateral disease).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

- Current or previous treatment with any GLP-1 receptor agonist (GLP-1- RA) within 90 days prior to the day of screening.
- Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinson’s disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.).
- 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.
- Planned arterial revascularisation known on the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.
- Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified