SGLT2 Inhibition and Left Ventricular Mass

Sponsor
Hannover Medical School
Study ID
NCT02728453
Phase
PHASE4
Status
Terminated

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
40 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.
  • Glimepiride — DRUG
    Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.

Study Details

Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type 2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance imaging and spectroscopy as well as echocardiography before and after empagliflozin or glimepiride treatment. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to position empagliflozin as an antidiabetic agent with the added value of protecting the heart.

Key Dates

Start date
Apr 27, 2016
Status verified
Jun 2018
Primary completion
Sep 25, 2017
Completion
Sep 27, 2017

Study Design

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

Arms

  • Experimental: Empagliflozin
    25 mg/d empagliflozin + matching glimepiride placebo for 24 weeks.
  • Active Comparator: Glimepiride
    2 or 4 mg/d glimepiride+ matching empagliflozin placebo for 24 weeks.

Primary Outcome Measure

change in left ventricular mass [ Time Frame: baseline and 24 weeks ]

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