Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease

Sponsor
Sheba Medical Center
Study ID
NCT03398577
Phase
PHASE4
Status
Unknown

Conditions

  • Coronary Disease With Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG [Farxiga] — DRUG
    Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.
  • Placebo Oral Tablet — DRUG
    Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.

Study Details

The aim of this study is to explore the effect of newly added SGLT2I medication or placebo, to standard medication regimen in diabetic patients with documented stable coronary disease. Therefore, in the present study the investigators plan to focus on possible anti-inflammatory and athero-thrombotic protective effects of Dapagliflozin compared to placebo, in secondary prevention population of stable coronary patients with diabetes. Additionally, the investigators will explore NT proBNP dynamics, which related to ventricular filling pressures in this specific population.

Key Dates

Start date
Feb 1, 2018
Status verified
Jan 2018
Primary completion
Aug 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
61 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Eligible patients (HbA1C ≥ 7% and ≤ 9%) , who were allocated to the Intervention group will receive Dapagliflozin 10 mg in addition to oral anti-diabetic medication administered prior to study enrollment.
  • Placebo Comparator: Control group
    Eligible patients (HbA1C ≥ 7% and ≤ 9%) , who were allocated to the Control group will receive placebo in addition to oral anti-diabetic medication administered prior to study enrollment.

Primary Outcome Measure

Percent reduction in interleukin (IL)-1β levels [ Time Frame: 3 months ]

Central Contacts