A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients

Sponsor
AstraZeneca
Study ID
NCT03387683
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    dapagliflozin 10mg
  • placebo — DRUG
    placebo to match dapagliflozin

Study Details

This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.

Key Dates

Start date
Feb 28, 2018
Status verified
Apr 2020
Primary completion
Mar 19, 2019
Completion
Mar 19, 2019

Study Design

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

Arms

  • Placebo Comparator: placebo
    placebo tablets once daily
  • Experimental: dapagliflozin 10mg
    dapagliflozin 10mg tablets once daily

Primary Outcome Measure

Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment. [ Time Frame: Baseline (Day 1) and end of treatment (Day 42) ]

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