LIGHT-MCI Trial: GLP-1 Agonist, SGLT2 Inhibitor, and DPP-4 Inhibitor for MCI Remission in Type 2 Diabetes

Summary

This is an investigator-led prospective, randomized, open label, parallel study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function in T2DM patients with mild cognitive impairment (MCI), consisting of a 48-week core study followed by a 28-week extension phase.

Conditions

• Type 2 Diabetes Mellitus
• Mild Cognitive Impairment

Interventions

DRUG

Liraglutide

Liraglutide will be titrated from 0.6mg/day to 1.8mg/day during the first 2 weeks, if well tolerated. All patients will also continue on their existing dose and regimen of metformin throughout the study

DRUG

Empagliflozin

Empagliflozin will be initiated and maintained at 10mg/ day every morning until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.

DRUG

Linagliptin

Iinagliptin will be initiated at 5mg/ day every morning until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• The Affiliated Jiangning Hospital of Nanjing Medical University

  collaborator OTHER

• Wuxi People's Hospital

  collaborator OTHER

• Changzhou No.2 People's Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Principal Investigators

• Yan Bi, MD, PhD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-08

Primary Completion

2025-12-31

Completion

2026-07-31

Countries

• China

Study Locations