Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes

Sponsor
Yonsei University
Study ID
NCT02964572
Status
Completed

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
19 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Glimepiride — DRUG
    In accordance with the standard treatment guidelines of diabetes, glimepiride as a drug of active comparator will be administered to improve blood sugar in patients with poorly controlled blood sugar.
  • Empagliflozin — DRUG
    Empagliflozin as a drug of experimental will be administered to improve blood sugar in patients with poorly controlled blood sugar.

Study Details

* Single-center, prospective, active-controlled, open, randomized, 2 arm parallel, interventional, exploratory pilot * Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic control with metformin-based oral hypoglycemic agents will be prescribed glimepiride (comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as add-on therapy * Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3 inflammasome activity from baseline to final timepoint will be assessed.

Key Dates

Start date
Nov 30, 2016
Status verified
Aug 2020
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Glimepiride
    Glimepiride (anti-diabetic drug) as a comparison group
  • Experimental: Empagliflozin
    Empagliflozin (anti-diabetic drug) as a study group

Primary Outcome Measure

changes in the secretion of IL-1 beta from peripheral blood mononuclear cells [ Time Frame: Day 60 ]

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