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

Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.

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.

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 30±3 and at 90±7 day.

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.