Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes

Sponsor
Unity Health Toronto
Study ID
NCT02998970
Phase
PHASE4
Status
Unknown

Conditions

  • Cardiovascular Disease
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    single oral tablet once daily.
  • Placebo — DRUG
    single oral tablet once daily.

Study Details

The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).

Key Dates

Start date
Jan 31, 2017
Status verified
Aug 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Placebo Comparator: Placebo
    The placebo group acts as a control group. This is in order to objectively isolate empagliflozin's effect on cardiac structure and function as determined by CMR imaging.
  • Active Comparator: Empagliflozin
    The study medication (Jardiance) is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death. The generic name is empagliflozin and will be provided by Boehringer-Ingelheim. If the patient is randomized into the study drug group patients will receive empagliflozin 10 mg tablets once daily for a duration of 6 months.

Primary Outcome Measure

Left Ventricular (LV) mass Changes [ Time Frame: 6 months ]

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