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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560998
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Peripheral Arterial Disease Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 13, 2022
Estimated Study Completion Date : November 28, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide given in addition to standard-of-care treatment
Drug: Semaglutide
Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.

Placebo Comparator: Placebo (semaglutide)
Placebo given in addition to standard-of-care treatment
Drug: Placebo (semaglutide)
Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

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

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

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

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

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

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

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

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

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

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

  15. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. 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.
    2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.
    3. 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.
    4. 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560998


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04560998    
Other Study ID Numbers: NN9535-4533
2019-003399-38 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1238-7071 ( Other Identifier: World Health Organization (WHO) )
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases