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UnknownPhase 4

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

NCT IDNCT04146155
Org study IDzhengchao

Timeline

Milestones

Study first posted2019-10-31actual
Study start2020-05-01actual
Last update posted2021-07-07actual
Primary completion2021-12-31estimated
Study completion2021-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersAccepted

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.

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

Cardiometabolic biomarkers
2
Other (unclassified)
2
Glycemic / diabetes
1
Other clinical outcomes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Changes from baseline in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Assess 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

Secondary/protocol endpoint

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 endpoint
Primary/protocol endpoint

Initial and absolute claudication distance

Time frame:24 weeks

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Muscle microvascular perfusion by CEU

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.