Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus

Sponsor
AstraZeneca
Study ID
NCT02426541
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks
  • Placebo — DRUG
    Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks

Study Details

This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus

Key Dates

Start date
Mar 23, 2015
Status verified
Jul 2017
Primary completion
Apr 28, 2016
Completion
Apr 28, 2016

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin Once Daily 10 mg
  • Placebo Comparator: Placebo
    Matching placebo for Dapagliflozin Once Daily 10 mg

Primary Outcome Measure

Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake [ Time Frame: From baseline to Week 8 ]

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