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

Summary

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.

Timeline

Start

2018-02-28

Primary completion

2019-03-19

Completion

2019-03-19

Outcome

Missed primary endpoint

registry analysis (other test); Dapagliflozin 10 mg vs Placebo; p = 0.504; Difference in LSM 0.31121 (95% CI -0.61900 to 1.24141); ANCOVA NCT03387683 ↗

Drugs

Indications