Effect of Dapagliflozin on Glycemic Variability

Sponsor
The Catholic University of Korea
Study ID
NCT02459353
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when added to insulin therapy. The primary objective of this study is to assess the effect of dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type 2 diabetic patients with inadequate glycemic control on insulin.

Key Dates

Start date
Aug 31, 2015
Status verified
Jul 2017
Primary completion
Dec 31, 2016
Completion
May 31, 2017

Study Design

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

Arms

  • Experimental: dapagliflozin 10mg
    a group which treated with dapagliflozin 10mg plus basal insulin therapy
  • Placebo Comparator: placebo 10mg
    a group which treated with dapagliflozin placebo plus basal insulin therapy

Primary Outcome Measure

Glycemic Variability (mean amplitude of glycemic excursion) [ Time Frame: baseline and 12 weeks ]

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