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

What Was Tested

The trial (not phased) is built around Liraglutide.

It had two arms (groups): active (active comparator) and standard care/no intervention (no intervention).

Active patients will receive liraglutide injections.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 1708 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;. Informed consent signed.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: diagnosis of hemorrhage brain disease on baseline head ct;; iatrogenic and cardiogenic stroke;; patients receiving thrombolysis or endovascular treatment;.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-06-25 with completion listed for 2023-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic) (time frame: 90 days).

It also tracked 2 secondary outcomes, for example Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 1708 people.

With 1708 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.