NCT05360147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

April 26, 2021

Last Update Submit

April 30, 2022

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusCognitive functionLiraglutideFunctional near-infrared spectroscopyMetabolic changes

Outcome Measures

Primary Outcomes (1)

  • Changes in cognitive function from baseline to 12 weeks

    MMSE

    0 week, 12 week

Secondary Outcomes (13)

  • Changes of metabolic parameters from baseline to 12 weeks

    0 week, 12 week

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

    0 week, 12 week

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

    0 week, 12 week

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

    0 week, 12 week

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

    0 week, 12 week

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Liraglutide

ACTIVE COMPARATOR

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

LiraglutideDRUG

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.

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

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Type 2 Diabetes Mellitus

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LiraglutideSulfonylurea CompoundsThiazolidinediones

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 4, 2022

Study Start

January 20, 2021

Primary Completion

April 20, 2021

Study Completion

May 10, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations

CN(1)