Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Third Military Medical University

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Liraglutide; Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides

Study type: Interventional

Funder types: Other

Identifiers

NCT05360147

LICD study

Details and patient eligibility

About

Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Here the investigators aim to further verify such effects through a randomized, controlled study.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 2 Diabetes Mellitus

Exclusion criteria

• T2DM with acute diabetic complications;
• type 1 diabetes;
• other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction);
• alcohol abuse, mental illness, and psychoactive substance abuse;
• history of thyroid disease;
• any surgical or medical conditions that could significantly influence the absorption, distribution, metabolism, or excretion of interventional drugs;
• unwillingness to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue

Treatment:

Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides

Liraglutide

Active Comparator group

Description:

liraglutide started at an initial dose of 0.6 mg/day and a maximum dose of 1.8mg/day, adjusted once a week when hyperglycemia was uncontrolled

Treatment:

Drug: Liraglutide