Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05360147

Enrollment

Registered

2022-05-04

Start date

2021-01-20

Completion date

2021-05-10

Last updated

2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes

Brief summary

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.

Interventions

DRUGLiraglutide

Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. We had fond its cognitive improvement effects in an observational study. In order to confirm the effects, the investigators conduct a randomized, controlled study.

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

oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in cognitive function from baseline to 12 weeks	0 week, 12 week	MMSE

Secondary

Measure	Time frame	Description
Changes of metabolic parameters from baseline to 12 weeks	0 week, 12 week	Systolic and diastolic blood pressure
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	0 week, 12 week	Aβ42

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026