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Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

NCT04137328 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Neuropathic Pain

Interventions

DRUG

Liraglutide

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

DRUG

insulin

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Bin Lu, doctor · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137328 on ClinicalTrials.gov