Ensayos clínicos

Inclusion Criteria

• 60 male and female subjects > 18 years of age.
• Type 2 diabetes mellitus.
• On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months.
• EF > 50% without diastolic dysfunction or EF > 50% with grade 2 or more diastolic dysfunction, without prior diagnosis, or signs and symptoms, of heart failure.
• Minimal distance of >450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and/or knees, and does not have fatigue or shortness of breath, then they will still qualify for the protocol.

Exclusion Criteria

• Age < 18 years.
• HbA1C > 9 % at enrollment.
• Prior diagnosis, or signs and symptoms, of heart failure.
• Currently taking a loop diuretic.
• Myocardial infarction within 6 months of  Visit 2.
• Unstable angina within 6 months of Visit 2.
• Significant (> moderate) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
• Severe congenital heart diseases.
• Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.
• Second or third degree heart block without a permanent cardiac pacemaker.
• Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
• ALT > 2 times the upper limit of normal.
• Serum sodium of  < 125 mEq/dL or > 160 mEq/dL.
• Serum potassium of < 3.5 mEq/dL or > 5.9 mEq/dL.
• Hemoglobin < 9 gm/dl.
• EGFR < 30 ml/min (at screening).
• Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data.
• Received an investigational drug within 1 month prior to dosing.
• Patients with an allergy to iodine.
• Female subject who is pregnant or breastfeeding.
• In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reason.