Peripheral arterial disease Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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, Appendix 8. - 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the effect of subcutaneous (s.c., under the skin) semaglutide 1 mg once-weekly on walking ability compared with placebo, both added to standard-of-care, in patients with type 2 diabetes (T2D) and peripheral arterial disease (PAD) with intermittent claudication.;Secondary Objective: The secondary objectives are to compare the effect of s.c. semaglutide 1 mg once-weekly versus placebo, both added to standard-of-care in patients with T2D and PAD with intermittent claudication with regards to: - PAD-specific health-related quality of life (VascuQoL-6) - Body weight - HbA1c - Lipids - Blood pressure - Non-invasive blood pressure indices (ankle-brachial index (ABI), toe-brachial index (TBI)) - Safety - Patient-reported walking ability (WIQ) - Patient reported health-related quality of life (SF-36);Primary end point(s): Change in maximum walking distance on a constant load treadmill test;Timepoint(s) of evaluation of this end point: From baseline (week 0) to end of treatment (week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Follow-up change in maximum walking distance on a constant load treadmill test 2. Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score 3. Change in pain-free walking distance on a constant load treadmill test 4. Follow-up change in pain-free walking distance on a constant load treadmill test 5. Change in glycosylated haemoglobin (HbA1c) 6. Change in body weight 7. Change in systolic blood pressure 8. Change in total cholesterol 9. Change in Low-density lipoprotein (LDL)-cholesterol 10. Change in High-density lipoprotein (HDL)-cholesterol 11. Change in triglycerides 12. Change in ankle-brachial index (ABI) 13. Change in toe-brachial index (TBI) 14. Change in Walking Impairment Questionnaire (WIQ) global score 15. Change in Short Form 36 (SF-36) physical functioning domain;Timepoint(s) of evaluation of this end point: 1. : From baseline (week 0) to end of follow-up (week 57) 2. - 3.:From baseline (week 0) to end of treatment (week 52) 4.: From baseline (week 0) to end of follow-up (week 57) 5. - 11.:From baseline (week 0) to end of treatment (week 52) 12. - 13.: From screening (week -2) to end of treatment (week 52) 14. - 15.: From baseline (week 0) to end of treatment (week 52) | — |
Countries
Austria, Belgium, Canada, China, Denmark, European Union, Germany, Hungary, India, Japan, Latvia, Malaysia, Norway, Russian Federation, Taiwan, Thailand, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed