- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146155
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Chao Zheng, MD, PhD
- Phone Number: 8615057585907
- Email: wallbb_1022@163.com
Study Locations
-
-
Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Contact:
- Youjin Pan, MD.
- Phone Number: 86057788002723
- Email: 526623800@qq.com
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Contact:
- Mengte Shi, MD.
- Phone Number: 86057788002713
- Email: smt198853@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Liraglutide+standard-of-care treatment
Intervention: Liraglutide is added to existing standard-of-care treatment containing one or more oral anti-hyperglycemic agents or insulin or a combination of these agents with the exception of other incretin and SGLT2i therapies.
|
Liraglutide is available if pre-filled pens (6 mg/ml) as a solution for injection (Victoza®). One ml of solution contains 6 mg of Liraglutide (human glucagon-like peptide-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae). One pre-filled pen contains 18 mg Liraglutide in 3 ml. Liraglutide is added to existing standard-of-care treatment containing one or more oral anti-hyperglycemic agents or insulin or a combination of these agents with the exception of other incretin and SGLT2i therapies in accordance with local clinical practice guidelines.
Other Names:
|
ACTIVE_COMPARATOR: standard-of-care treatment
standard-of-care treatment with the exception of incretin and SGLT2i therapies.
This approach expect to yield similar glycemic control in the two study groups.
|
Standard-of-care treatment including: metformin should be given as the first line therapy as long as it is tolerated and not contraindicated; other agents, including sulfonylureas or glucosidase inhibitor or insulin, should be added to metformin .Glycemic control will be managed by the investigators in accordance with local clinical practice guidelines by the adjustment of concomitant glucose-lowering agents or the addition of new antidiabetic medications with the exception of incretin and SGLT2i therapies.
This approach expect to yield similar glycemic control in the two study groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial and absolute claudication distance
Time Frame: 24 weeks
|
The primary outcome measures used to assess efficacy were pain-free walking distance (distance walked to the onset of symptoms, or the initial claudication distance [ICD]) and the maximum distance walked (absolute claudication distance [ACD]) on standardized treadmill testing.
Evaluation of walking performance was accomplished with standardized treadmill testing.
A constant speed of 3.2 km/h (2mile/h) and a fixed incline of 12.5% were used.
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24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the effects on ABI of a six month treatment with Liraglutide compared to control group (standard-of-care treatment).
Time Frame: 24 weeks
|
ankle-brachial index is ratio of ankle systolic pressure to arm systolic pressure: using a 10-12 cm sphygmomanometer cuff placed just above the ankle and a doppler instrument used to measure the systolic pressure of the posterior tibial and dorsalis pedis arteries of each leg.
These pressures are then normalized to the higher brachial pressure of either arm to form the ankle-brachial index (ABI).
The index leg is often defined as the leg with the lower ABI.
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24 weeks
|
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
|
Assess the effects on endothelial function of a six month treatment with Liraglutide compared to conventional treatment, assessed as the baseline corrected change in endothelial function by flow-mediated vasodilation (FMD) of the brachial artery at 6 months.
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24 weeks
|
Muscle microvascular perfusion by CEU
Time Frame: 24 weeks
|
Contrast enhanced ultrasound (CEU) performed by experienced radiologists is used for contrast ultrasonographic examination of skeletal muscle.
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24 weeks
|
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
|
Circulating progenitor cells (EPCs) will be quantified using flow cytometry before and after 6 month treatment GLP-1 receptor agonist or conventional therapy (control group).
Briefly, after erythrocyte lysis, peripheral blood will be stained with 10µL fluorescein isothiocyanate-conjugated anti-human CD34 mAb, 10µL phycoethrin-conjugated anti-human KDR mAb, and 10µL allophycocyanin-conjugated anti-CD133 mAb.
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24 weeks
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Changes from baseline in HbA1c
Time Frame: 24 weeks
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Change from baseline to last assessment during the treatment period in HbA1c
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24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Youjin Pan, MD., Second Affiliated Hospital of Wenzhou Medical University
- Principal Investigator: Xia Li, MD,PhD, Central South University
- Principal Investigator: Li Li, MD., Ningbo Hospital of Zhejiang University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Atherosclerosis
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Liraglutide
Other Study ID Numbers
- zhengchao
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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