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Efficacy and Safety of Liraglutide in Type 2 Diabetes With Lower Extremity Arterial Disease
Liraglutide Efficacy and Action on Type 2 Diabetes With Peripheral Atherosclerotic intErmittent Claudication (LEADPACE STUDY): a Prospective, 24-week, Multicenter, Randomized, Controlled Clinical Study
Asset
Liraglutide
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
200
estimated
Study population
Cardiovascular disease, Type 2 diabetes
Key I/E criterion
•HbA1c ≤14%
Primary endpoint
•Initial and absolute claudication distance
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointChanges from baseline in HbA1c
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
2 endpointsAssess the effects on ABI of a six month treatment with Liraglutide compared to control group (standard-of-care treatment).
Time frame:24 weeks
ratio, improvement
Assess the effects on endothelial function of a six month treatment with Liraglutide compared to control group (standard-of-care treatment).
Time frame:24 weeks
change from baseline, improvement
Other clinical outcomes
1 endpointInitial and absolute claudication distance
Time frame:24 weeks
change from baseline, improvement
Other (unclassified)
2 endpointsMuscle microvascular perfusion by CEU
Time frame:24 weeks
descriptive
Assess the effects on the endothelial circulating progenitor cells concentration of a six month treatment with Liraglutide compared to control group (standard-of-care treatment).
Time frame:24 weeks
concentration, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Cochrane database of systematic reviews2021 Oct 25PMID34693515doi:10.1002/14651858.CD013650.pub2via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.