A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2022/04/042104
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 33
Patients are eligible to be included in the trial only if all of the following criteria apply:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. 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, Section 10.8.
3. Diagnosed with type 2 diabetes mellitus = 180 days prior to the day of screening.
4. 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 > 200 m/656 feet/2 blocks) for = 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
= 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 = 600 meters/1968 feet.
d) Ankle-brachial-index (ABI) = 0.90 or toe-brachial index (TBI) = 0.70 (the leg with lowest
index is chosen in case of bilateral disease).
5. For patients receiving PAD standard of care non-drug (e.g. exercise) or drug therapy (e.g. statin,
cilostazol or pentoxifylline), treatment must have been stable for at least 90 days prior to the day
of screening, as judged by investigator.
6. HbA1c =10% (=86 mmol/mol) based on latest available measurements prior to randomisation
(visit 2). Laboratory results for inclusion can be based on medical records (no more than 90 days
old at screening) or central laboratory measurement obtained at the screening visit.
All exclusion criteria are based on the patient´s medical records, except for exclusion criterion 3, which is based on pregnancy test. Furthermore, exclusion criterion 12 (renal impairment) may be
based on assessment of eGFR by the central laboratory.
Patients are excluded from the trial, if any of the following criteria apply:
1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as randomisation.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
potential and not using a highly effective contraceptive method (see Appendix 4, Section 10.4 for
further guidance). For country specific requirements see Appendix 8, Section 10.8.
4. Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 90 days before screening.
5. Current or previous treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.
6. 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.).
India For country-specific requirements, please refer to Appendix 8 (Section 10.8)
7. Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening
(surgery affecting walking ability).
8. Vascular revascularisation procedure of any kind 180 days prior to the day of screening.
9. Planned arterial revascularisation known on the day of screening.
10. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic
attack (TIA) within 180 days prior to the day of screening.
11. Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.
India: For country-specific requirements, please refer to Appendix 8 (Section 10.8)
12. Renal impairment based on latest available measurements/evaluation prior to randomisation
(visit 2). Renal impairment can be diagnosed based on an estimated Glomerular Filtration Rate
(eGFR) value of eGFR < 30ml/min/1.73 m2 (measured within last six months) as defined by KDIGO 20122 or chronic or intermittent haemodialysis or peritoneal dialysis.
13. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
14. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
15. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.b Verified by a fundus
examination performed within the past 90 days prior to screening or in the period between
screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a
digital fundus photography camera specified for non-dilated examination.
16. Any disorder, which in the investigator’s opinion might jeopardise patient´s safety or compliance with the protocol.
17. For Hungary only: Presence or hist
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in maximum walking distance on a constant load treadmill testTimepoint: Time Frame: From baseline (week 0) to end of treatment (week 52) Unit: Ratio to baseline (no unit)
- Secondary Outcome Measures
Name Time Method