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CompletedNCT05360147Updated May 4, 2022

Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

A Phase 3 interventional study of Liraglutide and Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides in Type 2 Diabetes Mellitus, sponsored by Third Military Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Third Military Medical University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2021, registered Apr 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus
  • Cognitive function
  • Liraglutide
  • Functional near-infrared spectroscopy
  • Metabolic changes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with Type 2 Diabetes Mellitus

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Placebo comparator
    Placebo

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

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

  • Active comparator
    Liraglutide

    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

    Drug: Liraglutide

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

06

What researchers measure

Primary outcomes

  1. Changes in cognitive function from baseline to 12 weeks

    MMSE

    Time frame: 0 week, 12 week

Secondary outcomes

  1. Changes of metabolic parameters from baseline to 12 weeks

    Systolic and diastolic blood pressure

    Time frame: 0 week, 12 week

  2. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Aβ42

    Time frame: 0 week, 12 week

  3. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    tau

    Time frame: 0 week, 12 week

  4. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    P-tau

    Time frame: 0 week, 12 week

  5. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    TDP-43

    Time frame: 0 week, 12 week

  6. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    IL-6

    Time frame: 0 week, 12 week

  7. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    IL-8

    Time frame: 0 week, 12 week

  8. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    TNF-a

    Time frame: 0 week, 12 week

  9. Changes of metabolic parameters from baseline to 12 weeks

    HbA1c

    Time frame: 0 week, 12 week

  10. Changes of metabolic parameters from baseline to 12 weeks

    fasting plasma glucose

    Time frame: 0 week, 12 week

  11. Changes of metabolic parameters from baseline to 12 weeks

    body mass index

    Time frame: 0 week, 12 week

  12. Changes of metabolic parameters from baseline to 12 weeks

    lipid profile

    Time frame: 0 week, 12 week

  13. Changes of metabolic parameters from baseline to 12 weeks

    waist circumference

    Time frame: 0 week, 12 week

07

Study locations

1 site
  • The third hospital affiliated to the Third Military Medical University
    Chongqing, Chongqing 400042, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05360147
Lead sponsor
Third Military Medical University
Responsible party
Zhiming Zhu (Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital, Third Military Medical University) — Principal investigator
First posted
May 4, 2022
Start date
Jan 20, 2021
Primary completion
Apr 20, 2021
Completion
May 10, 2021
Last update
May 4, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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