Efficacy and Safety of Liraglutide in Type 2 Diabetes With Lower Extremity Arterial Disease
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 40 Years to no upper limit; healthy volunteers accepted; no BMI minimum stated; conditions: Type 2 Diabetes; Peripheral Vascular Disorder Due to Diabetes Mellitus
- Interventions
- Liraglutide+standard-of-care treatment; standard-of-care treatment
- Conditions
- Type 2 Diabetes; Peripheral Vascular Disorder Due to Diabetes Mellitus
- Phase and size
- Phase 4 · 200 participants
- Dates
- Start 2020-05-01
Primary completion 2021-12-31 - Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Initial and absolute claudication distance24 weeks
02Eligibility
Who can take part
Inclusion Criteria: * Informed consent * type 2 diabetes (1999 WHO criteria) * 7.5≤HbA1c ≤14% * Age \> 40 years * lower extremity PAD with symptom * Absence of distal arterial pulse. * ABI less than 0.9 or the value decreased by more than 15% after treadmill test. * Presence of stenosis or occlusion of lower extremity arteries as determined by Duplex ultrasound imaging or lower extremity CTA; or lower extremity DSA(Digital Substraction Angiography). Exclusion Criteria: * Type 1 diabetes * Other Concomitant illness: 1\) poorly controlled hypertension: \>160 mmHg systolic blood pressure and/or\>100 mmHg diastolic blood pressure (with or without long-term oral antihypertensive drugs); 2) Chronic heart failure NYHA class (III-IV); 3) An acute coronary or cerebro-vascular event within the previous 6 months; 4) hematological malignancies such as acute or chronic myeloid leukemia, or any other hematological disorders that would interfere with the determination of circulating EPC levels; 5) Personal history of non-familial medullary thyroid carcinoma; 6) Immunological disorders such as lupus, psoriasis, scleroderma and rheumatoid arthritis which would interfere with the determination of circulating EPC levels; 7) Chronic haemodialysis or chronic peritoneal dialysis; 8) End stage liver disease, presence of acute or chronic liver disease or recent history of the following: ALT level ≥ 3 times the upper limit of normal, or AST level ≥ 3 times the upper limit of normal; 9) Severe gastrointestinal diseases, such as gastrointestinal ulcer, gastrointestinal bleeding, pyloric stenosis, gastric bypass surgery; 10) History of chronic pancreatitis or idiopathic acute pancreatitis; 11) Any acute condition or exacerbation of chronic condition that would in the Investigator's opinion interfere with the initial trial visit schedule and procedures; 12) Inability to walk on a tredamill without grade at a speed of at least 3.2 km/h for at least 2 minutes. * Drugs: 1) Known or suspected hypersensitivity to trial products or related products ; 2) Use of GLP-1 receptor agonist (exenatide (BID or OW), liraglutide, or other) within 6 months prior to screening; 3).Alcohol or drugs abuse. * 4\. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening. * Recent (within 6 months) surgery or trauma. * Pregnancy and lactation. * Psychiatric disorders * Simultaneous participation in any other clinical trial of an investigational agent.
03Change log
Registry changes
No changes recorded since the trial was added.