Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
NCT ID: NCT03948347
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1708 participants
INTERVENTIONAL
2019-06-25
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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active
Active patients will receive liraglutide injections
Liraglutide
The treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days.
standard care/no intervention
standard care for stroke as per hospital protocol
No interventions assigned to this group
Interventions
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Liraglutide
The treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
* High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
* First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
* Informed consent signed.
Exclusion Criteria
* Iatrogenic and cardiogenic stroke;
* Patients receiving thrombolysis or endovascular treatment;
* Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
* Patients with pancreatitis or previous history of pancreatitis, inflammatory bowel disease and gastroparesis;
* Pregnant, lactating women,or patients who are likely to have a pregnancy and plan to have one;
* Allergic to liraglutide or excipients;
* Congestive heart failure (NYHA class III-IV);
* Severe liver and kidney dysfunction (AST/ALT is 3 times higher than the normal upper limit, serum creatinine is 3 times higher than the normal upper limit);
* Patients with malignant tumors who are expected to have a survival period of less than three months;
* Participated in other clinical trials of drugs within 3 months;
* Researchers believe that patients who are not suitable for this clinical study.
50 Years
ALL
No
Sponsors
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First Affiliated Hospital of Jinan University
OTHER
Responsible Party
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Anding Xu
Dean of the First Affiliated Hospital of Jinan University
Locations
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The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAMP20190508
Identifier Type: -
Identifier Source: org_study_id
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