NCT04137328|Unknown
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Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2019
Actual (reported)October 24, 2019
Actual (reported)November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Numerical pain scale (NRS)
The number of 0-10 represents the degree of pain of the patient, 0 is no pain, 10 is extreme pain. How to write: circle the number that describes the most severe pain in the last 24 hours.
3 months
Neurological symptom score (NSS) / neurological deficit score (NDS)
3 months
Examination of nerve conduction function
3 months
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.
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.
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
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
Jeffcoate WJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcers. Diabetes Care. 2018 Apr;41(4):645-652. doi: 10.2337/dc17-1836.
Lu B, Yang Z, Wang M, Yang Z, Gong W, Yang Y, Wen J, Zhang Z, Zhao N, Zhu X, Hu R. High prevalence of diabetic neuropathy in population-based patients diagnosed with type 2 diabetes in the Shanghai downtown. Diabetes Res Clin Pract. 2010 Jun;88(3):289-94. doi: 10.1016/j.diabres.2010.02.002. Epub 2010 Mar 31.
Bin Lu, doctor
Huashan Hospital
First Submitted
October 22, 2019
First Posted
October 24, 2019
Study Start
November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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Kanera IM, van Laake-Geelen CCM, Ruijgrok JM, Goossens MEJB, de Jong JR, Verbunt JA, Geerts M, Smeets RJEM, Kindermans HPJ. Living with painful diabetic neuropathy: insights from focus groups into fears and coping strategies. Psychol Health. 2019 Jan;34(1):84-105. doi: 10.1080/08870446.2018.1518526. Epub 2018 Oct 15.
Tsuda M. Microglia in the spinal cord and neuropathic pain. J Diabetes Investig. 2016 Jan;7(1):17-26. doi: 10.1111/jdi.12379. Epub 2015 Jun 23.
Inoue K, Tsuda M. Microglia in neuropathic pain: cellular and molecular mechanisms and therapeutic potential. Nat Rev Neurosci. 2018 Mar;19(3):138-152. doi: 10.1038/nrn.2018.2. Epub 2018 Feb 8.
Hirano T, Mori Y. Anti-atherogenic and anti-inflammatory properties of glucagon-like peptide-1, glucose-dependent insulinotropic polypepide, and dipeptidyl peptidase-4 inhibitors in experimental animals. J Diabetes Investig. 2016 Apr;7 Suppl 1(Suppl 1):80-6. doi: 10.1111/jdi.12446. Epub 2016 Mar 31.
Bruen R, Curley S, Kajani S, Crean D, O'Reilly ME, Lucitt MB, Godson CG, McGillicuddy FC, Belton O. Liraglutide dictates macrophage phenotype in apolipoprotein E null mice during early atherosclerosis. Cardiovasc Diabetol. 2017 Nov 6;16(1):143. doi: 10.1186/s12933-017-0626-3.
Vinue A, Navarro J, Herrero-Cervera A, Garcia-Cubas M, Andres-Blasco I, Martinez-Hervas S, Real JT, Ascaso JF, Gonzalez-Navarro H. The GLP-1 analogue lixisenatide decreases atherosclerosis in insulin-resistant mice by modulating macrophage phenotype. Diabetologia. 2017 Sep;60(9):1801-1812. doi: 10.1007/s00125-017-4330-3. Epub 2017 Jun 12.
Lee CH, Jeon SJ, Cho KS, Moon E, Sapkota A, Jun HS, Ryu JH, Choi JW. Activation of Glucagon-Like Peptide-1 Receptor Promotes Neuroprotection in Experimental Autoimmune Encephalomyelitis by Reducing Neuroinflammatory Responses. Mol Neurobiol. 2018 Apr;55(4):3007-3020. doi: 10.1007/s12035-017-0550-2. Epub 2017 Apr 29.
Barros JI, Fechine FV, Montenegro Junior RM, Vale OC, Fernandes VO, Souza MH, Cunha GH, Moraes MO, d'Alva CB, Moraes ME. Effect of treatment with sitagliptin on somatosensory-evoked potentials and metabolic control in patients with type 2 diabetes mellitus. Arq Bras Endocrinol Metabol. 2014 Jun;58(4):369-76. doi: 10.1590/0004-2730000002914.
November 30, 2022
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 25, 2019
Record last verified: 2019-10
we have no plan to make individual participant data (IPD) available to other researchers
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