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Clinical Trial Details

Trial ID: L3693
Source ID: NCT02964572
Associated Drug: Glimepiride
Title: Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Glimepiride|DRUG: Empagliflozin
Outcome Measures: Primary: changes in the secretion of IL-1 beta from peripheral blood mononuclear cells, The effect of empagliflozin on the secretion of IL-1beta from peripheral blood mononuclear cells, Day 60 | Secondary: Changes in the secretion of TNF-alpha from peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of beta-hydroxybutyrate, before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in body weight (kg), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of insulin (µU/mL), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of glucagon (pg/mL), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of free fatty acid (μEq/L), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum glycated albumin (%), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of glucose (mg/dL), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of uric acid (mg/dL), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in serum concentrations of creatinine (mg/dL), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in spot urine concentrations of glucose (mg/dL) and creatinine (mg/dL) (those will be combined to report spot urine glucose-to-creatinine ratio in mg/mg), before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in mRNA expression level (PCR, fold) of IL-1beta, TNF-alpha, and NLRP3 in peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days|Changes in protein expression pattern (western blot, relative to control) of IL-1beta, TNF-alpha, and NLRP3 in peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride, Day 60 plus or minus 32 days
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 61
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2017-07
Results First Posted:
Last Update Posted: 2020-08-27
Locations: Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02964572