Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

Sponsor
Fudan University
Study ID
NCT04137328
Status
Unknown

Conditions

  • Diabetic Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — 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

Study Details

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.

Key Dates

Start date
Nov 30, 2019
Status verified
Oct 2019
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: liraglutide group
    Mecobalamin tablets (0.5mg/day, oral) and liraglutide (0.6mg/day in the first week, if there is no obvious discomfort, 1.2mg/day in the second week, subcutaneous injection) were used for 3 months.
  • Active Comparator: control group
    Take Mecobalamin (0.5mg/day, oral), add or adjust insulin (when basic insulin is preferred for those who do not use insulin, if insulin has been used, adjust the dose or program according to the condition, inject subcutaneously) for 3 months.

Primary Outcome Measure

Numerical pain scale (NRS) [ Time Frame: 3 months ]

Central Contacts

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