Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus

  • STATUS
    Recruiting
  • End date
    May 16, 2023
  • participants needed
    1708
  • sponsor
    First Affiliated Hospital of Jinan University
Updated on 17 February 2021

Summary

The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS 3) or high-risk transient ischemic attack (TIA) (ABCD2 score 4 ) patients with type 2 diabetes mellitus.

Description

The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 303 and at 907 day.

Details
Condition NIDDM, Diabetes Mellitus, Transient Ischemic Attack, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Ischemic Stroke, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2, transient ischemic attacks
Treatment Liraglutide
Clinical Study IdentifierNCT03948347
SponsorFirst Affiliated Hospital of Jinan University
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult subjects (male or female 50 years)
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

Diagnosis of hemorrhage brain disease on baseline head CT
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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