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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke Transient Ischemic Attack Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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active

Active patients will receive liraglutide injections

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

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

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Jinan University

OTHER

Sponsor Role lead

Responsible Party

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Anding Xu

Dean of the First Affiliated Hospital of Jinan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Anding Xu, M.D, Ph.D

Role: CONTACT

+86 013392692160

Huili Zhu, M.D

Role: CONTACT

+86 013922165588

Facility Contacts

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Anding Xu, M.D, Ph.D

Role: primary

+86 013392692160

Huili Zhu, M.D

Role: backup

+86 013922165588

Other Identifiers

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LAMP20190508

Identifier Type: -

Identifier Source: org_study_id

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