Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics

Sponsor
Johannes Gutenberg University Mainz
Study ID
NCT02932436
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    10 mg per os daily for 12 weeks
  • Placebo — DRUG
    amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks

Study Details

The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function in patients with type 2 Diabetes mellitus.

Key Dates

Start date
Oct 10, 2016
Status verified
Apr 2021
Primary completion
Jun 15, 2020
Completion
Aug 31, 2020

Study Design

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

Arms

  • Experimental: Empagliflozin
    10 mg Empagliflozin daily per os for 12 weeks
  • Experimental: Placebo
    amount of Placebo corresponding to empagliflozin 10 mg daily per os for 12 weeks

Primary Outcome Measure

difference in E/E' ratio between 12 weeks after baseline and at baseline [ Time Frame: 12 weeks ]

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