← Human Trials & Peer-Reviewed Studies
Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Plain-language guide to NCT03707171: phase 3 non-randomized trial of Liraglutide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03707171
- Phase
- phase 3
- Status
- completed
- Start
- 2018-10-01
- Completion (planned or actual)
- 2019-02-01
- Participants
- 30 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Liraglutide.
Type 2 diabetes mellitus (T2DM) can impaire cognitive function,the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population.Cognitive impairment seriously affects the health and quality of life of the elderly.
It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).
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 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes。.
The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: type 2 diabetes with acute diabetic complications; type 1 diabetes; other diseases affecting cognitive function (congenital dementia,brain trauma,severe heart dysfunction,severe kidney dysfunction,severe lung dysfunction,epilepsy,severe hypoglycemic coma,cerebrovascular disease,ischemic heart disease,etc).
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2018-10-01 with completion listed for 2019-02-01.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Changes of cognitive function assessed by cognitive function scale after 12 weeks (time frame: Baseline,4weeks,8weeks，12weeks(End of Trial)).
It also tracked 11 secondary outcomes, for example Changes of systolic blood pressure and diastolic blood pressure, Change of fasting plasma glucose, Change of HbA1c, Change of lipid profile, Change of liver enzymes and Change of kidney function.
What This Means in Plain Language
Put simply, this is a phase 3, non-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.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.