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Clinical Trials List

Protocol NumberNN9535-4533
NCT Number(ClinicalTrials.gov Identfier)NCT04560998
Completed

2020-10-01 - 2024-12-31

Phase III

Not yet recruiting2

Recruiting1

Terminated4

ICD-10E08.51

Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene

ICD-10E08.52

Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene

ICD-10E08.59

Diabetes mellitus due to underlying condition with other circulatory complications

ICD-10E09.51

Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy without gangrene

ICD-10E09.52

Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangrene

ICD-10E09.59

Drug or chemical induced diabetes mellitus with other circulatory complications

ICD-10E11.51

Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene

ICD-10E11.52

Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene

ICD-10E11.59

Type 2 diabetes mellitus with other circulatory complications

ICD-10E13.51

Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene

ICD-10E13.52

Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene

ICD-10E13.59

Other specified diabetes mellitus with other circulatory complications

ICD-9250.70

Diabetes with peripheral circulatory disorders, Type II [non-insulin dependent type][NIDDM type][adult-onset type] or unspecified type ,not stated as uncontrolled

Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    Novo Nordisk A/S

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yu-Yao Huang Division of Endocrinology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator JEN-KUANG LEE Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Horng-Yih Ou Division of Endocrinology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ching-Chu Chen 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Tsung-Hsien Lin 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 曾士婷 無
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Liang-Yu Lin Division of Endocrinology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Diabetes Mellitus, Type 2/Peripheral Arterial Disease

Objectives

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.

Test Drug

Semaglutide 1.34 mg/ml / placebo

Active Ingredient

Semaglutide B

Dosage Form

Solution for Injection

Dosage

1.34

Endpoints

Primary Outcome Measures :
Change in maximum walking distance on a constant load treadmill test [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline


Secondary Outcome Measures :
Change in pain-free walking distance on a constant load treadmill test [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline

Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Score on a scale. Vascular Quality of Life 6 (VascuQoL): A shorter version of the standardized, validated questionnaire, VascuQoL-25 which is used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 4 point response scale, with a score of 1 being the worst and a score of 4 the best possible. The total score is the sum of all 6 items scores. Each question relates to a separate domain, with a highest score of 4 which indicates best health outcome. The VascuQoL-6 is aimed specifically at PAD patients

Follow-up change in maximum walking distance on a constant load treadmill test [ Time Frame: From baseline (week 0) to end of follow-up (week 57) ]
Ratio to baseline

Follow-up change in pain-free walking distance on a constant load treadmill test [ Time Frame: From baseline (week 0) to end of follow-up (week 57) ]
Ratio to baseline

Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Percentage point

Change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Kilogram

Change in systolic blood pressure [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
mmHg

Change in total cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline

Change in Low-density lipoprotein (LDL)- cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline

Change in High density lipoprotein (HDL)- cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline

Change in triglycerides [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Ratio to baseline

Change in ankle-brachial index (ABI) [ Time Frame: From screening (week -2) to end of treatment (week 52) ]
Ratio

Change in toe-brachial index (TBI) [ Time Frame: From screening (week -2) to end of treatment (week 52) ]
Ratio

Change in Walking Impairment Questionnaire (WIQ) global score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Percentage point

Change in Short Form 36 (SF-36) physical functioning domain [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
Score on a scale. Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health, of which will be summarised into a physical health. The physical score ranges from 24-101(where higher scores indicate a better physical capability). The domain scores will then be transformed into norm-based scores. At least seven domains must have valid data in order to calculate the physical health. To calculate physical health, the physical domain must be one of these seven domains. These scores will be summarised by domains and component summary scores by treatment and visit. A positive change in score indicates an improvement since baseline

Inclution Criteria

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 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:

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).

Exclusion Criteria

Exclusion Criteria:

Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) or dipeptidyl-peptidase 4 (DPP4) inhibitor 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.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    800 participants

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