Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 470
- 主要终点
- Change in Maximum Walking Distance on a Constant Load Treadmill Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
- •Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
- •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 less than 600 meters/1968 feet.
- •Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).
排除标准
- •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.
研究组 & 干预措施
Placebo (semaglutide)
Placebo given in addition to standard-of-care treatment
干预措施: Placebo (semaglutide) (Drug)
Semaglutide
Semaglutide given in addition to standard-of-care treatment
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in Maximum Walking Distance on a Constant Load Treadmill Test
时间窗: Baseline (week 0), end of treatment (week 52)
Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
次要结局
- Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test(Baseline (week 0), end of follow-up (week 57))
- Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score(Baseline (week 0), end of treatment (week 52))
- Change in Pain-free Walking Distance on a Constant Load Treadmill Test(Baseline (week 0), end of treatment (week 52))
- Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test(Baseline (week 0), end of follow-up (week 57))
- Change in Glycosylated Haemoglobin (HbA1c)(Baseline (week 0), end of treatment (week 52))
- Change in Body Weight(Baseline (week 0), end of treatment (week 52))
- Change in Systolic Blood Pressure(Baseline (week 0), end of treatment (week 52))
- Change in Total Cholesterol(Baseline (week 0), end of treatment (week 52))
- Change in Low-density Lipoprotein (LDL)-Cholesterol(Baseline (week 0), end of treatment (week 52))
- Change in High Density Lipoprotein (HDL)-Cholesterol(Baseline (week 0), end of treatment (week 52))
- Change in Triglycerides(Baseline (week 0), end of treatment (week 52))
- Change in Ankle-Brachial Index (ABI)(Screening (week -2), end of treatment (week 52))
- Change in Toe-Brachial Index (TBI)(Screening (week -2), end of treatment (week 52))
- Change in Walking Impairment Questionnaire (WIQ) Global Score(Baseline (week 0), end of treatment (week 52))
- Change in Short Form 36 (SF-36) Physical Functioning Domain(Baseline (week 0), end of treatment (week 52))