CTRI/2022/04/042104进行中（未招募）3 期
Effects of semaglutide on functional capacity in patients withtype 2 diabetes and peripheral arterial disease (STRIDE) - Nil
ovo Nordisk AS0 个研究点目标入组 33 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
排除标准
- •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
研究者
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