BENITIONSClinical Trial Intelligence

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Фаза 3 Завершено NCT04560998

ЗаболеваниеDiabetes Mellitus, Type 2, Peripheral Arterial Disease
ФазаФаза 3
СпонсорNovo Nordisk A/S
СтатусЗавершено
Участники792 участн.
ВмешательствоSemaglutide, Placebo (semaglutide)
Дата начала1.10.2020
Дата завершения5.06.2024
Публикация результатов8.07.2025

Кратко

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.

Change in Maximum Walking Distance on a Constant Load Treadmill Test

Baseline (week 0), end of treatment (week 52) · Ratio of maximum walking distance

Semaglutide1.21 Ratio of maximum walking distance
Placebo1.08 Ratio of maximum walking distance
p-value0.0004
The Hodges-Lehmann estimate1.13 (95% CI 1.056–1.211)

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