Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT02610088
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by \> 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion.
  • Gliclazide — DRUG
    Gliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by \> 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion.

Study Details

The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes

Key Dates

Start date
Nov 30, 2015
Status verified
Sep 2018
Primary completion
Jul 31, 2018
Completion
Sep 30, 2018

Study Design

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

Arms

  • Active Comparator: Dapagliflozin
    Dapagliflozin will be started in patient with type 2 diabetes mellitus
  • Active Comparator: Gliclazide
    Gliclazide will be started in patient with type 2 diabetes mellitus

Primary Outcome Measure

Vascular function assessed by Flow-mediated vasodilation (FMD) [ Time Frame: 24weeks ]

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