Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

Here the investigators aim to further verify such effects through a randomized, controlled study.

It had two arms (groups): Placebo (placebo comparator) and Liraglutide (active comparator).

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

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Patients with Type 2 Diabetes Mellitus.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: 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);.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-01-20 with completion listed for 2021-04-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in cognitive function from baseline to 12 weeks (time frame: 0 week, 12 week).

It also tracked 13 secondary outcomes, for example Changes of metabolic parameters from baseline to 12 weeks, Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks, Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks, Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks, Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks and Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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