Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus on oral therapy

• Stable documented ischemic Heart disease (> 60 days post AMI, CABG or PCI)

• Sub-optimal Hb A1c defined as ≥ 7%

• Age > 21

• Life expectancy >1 year

Exclusion Criteria:

• Events of clinical hypoglycemia during the past 6 months

• Recent (< 60 days) acute coronary syndrome (ACS) or Cerebrovascular accident

• Transient ischemic attack (TIA) within the past year.

• Significant renal impairment (eGFR < 60 ml/min/1.73 m2)

• History of recurrent UTI \ vaginitis

• Past bladder cancer (TCC or other)

• History of diabetic keto-acidosis

• Planned coronary intervention or planed surgical intervention (PCI or CABG)

• Unstable arrhythmias (i.e. rapid atrial fibrillation, symptomatic bradycardia, recurrent ventricular arrhythmia that are clinically significant, etc.)

• Known hypersensitivity to study drug

• Type I diabetes

• Current Hb A1c >9%

• Current Insulin treatment

• Active treatment with SGLT2I medication

• Inability to comply with study protocol

• Active malignancy other than basal cell carcinoma (BCC)

• Clinically advanced congestive heart failure - NYHA class III-IV

• Severe left ventricular dysfunction (LVEF<30%) with NYHA II or any NYHA class with documented recent heart failure decompensation (<3 months)

• Severe stable cardiac angina CCS III - IV or Unstable angina

• Chronic inflammation (i.e. IBD, Lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)

• Pregnancy, lactation or child-bearing potential