Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
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.
Inclusion Criteria:
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
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:
Exclusion Criteria:
North York, Ontario M6B 3H7, Canada
North York, Ontario M6B 3H7, Canada
Xi'an, Shaanxi 710061, China
Ostrava Dubina, 700 30, Czechia
Ostrava Dubina, 700 30, Czechia
Saint Ingbert-Oberwürzbach, 66386, Germany
New Delhi, National Capital Territory of Delhi 110002, India
New Delhi, National Capital Territory of Delhi 110062, India
New Dehli, New Delhi 110029, India
Chandigarh, Punjab 160012, India
Chiba-shi, Chiba, 260-0804, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Moscow, 117292, Russia
Muang, Changwat Khon Kaen 40002, Thailand