Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

NCT04137328 · Unknown status

Last updated 2026-05-28

This clinical trial is testing whether the medication liraglutide can help reduce pain in people with diabetic nerve damage.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 60 people Planned (estimated).

Who can join Ages 18–80 · all sexes

Timeline Started 2019-11 · est. completion 2022-11

What this study is testing ClinicalTrials.gov NCT04137328 ↗

Description as written by the study sponsor.

Diabetic neuropathic pain is a common clinical manifestation of diabetic neuropathy, which seriously affects the quality of life of patients. The clinical treatment is limited and the curative effect is not good. In the previous animal studies, investigators found that the change of pain threshold in diabetic rats showed a staged change, and was significantly related to the change of brain microglia activity. It was confirmed that liraglutide could regulate the activation of microglia in vitro. Then investigators found that it could intervene diabetic neuropathic pain through the intervention of liraglutide in diabetic rats. In the early stage of clinical observation, the investigators also preliminarily observed that liraglutide can intervene diabetic neuropathic pain. At present, liraglutide is a commonly used hypoglycemic drug in clinic. Therefore, on the basis of previous studies, this study intends to select diabetic neuropathic pain patients whose blood sugar is not up to the standard, and give Mecobalamin to treat diabetic neuropathy. In addition, on the basis of the original hypoglycemic treatment, participants are randomly divided into one group to give liraglutide, one group to increase or adjust insulin, with similar blood glucose level. The improvement of diabetic neuropathic pain was observed. The aim of this study was to evaluate the safety and efficacy of liraglutide in improving diabetic neuropathic pain.

Treatments tested

Liraglutide also known as GLP-1RA Drug

0.6mg/day in the first week, if there is no obvious discomfort, 1.2mg/day in the second week, subcutaneous injection, lasting for 3 months
insulin Drug

Add or adjust insulin (when basic insulin is preferred for those who do not use insulin, such as those who have already used insulin, adjust the dosage or program according to the condition, inject subcutaneously) for 3 months

Main thing measured	Numerical pain scale (NRS)
Sponsor	Fudan University
Conditions studied	Diabetic Neuropathic Pain
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04137328 ↗