PDD in Type 2 Diabetes w/wo Diastolic Dysfunction

Korábbi kezelés

• prior diagnosis, or signs and symptoms, of heart failure;
• Currently taking a loop diuretic
• received an investigational drug within 1 month prior to dosing;

Más betegség

• 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
• 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
• patients with an allergy to iodine

Laborértékek

• HbA1C> 9 % at enrollment
• 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

Egyéb

• sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
• 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

• 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 not fatigue or shortness of breath, then they will still qualify for the protocol.