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

Exclusion Criteria

• •Female subjects who are pregnant, lactating or of child bearing potential, or pre-menopausal women. (Menopause will be determined by patient and physician history)
• •Type 1 diabetes
• •Subjects currently treated with SGLT2 inhibitors, Glucagon-like peptide-1 (GLP1) receptor agonist, or saxagliptin
• •Frequent episodes (\>4/month) of moderate hypoglycaemia, as defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
• •Any episode of severe hypoglycaemia within the past 12 months, as also defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
• •Subjects in whom coronary revascularisation by either Percutaneous coronary intervention (PCI) or bypass surgery is being contemplated within 6 months, or who have undergone revascularisation in the prior 2 months
• •Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)\< 60 ml/min/1.73 m2 at screening
• •Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations
• •Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, haematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease and psychiatric disease
• •Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
• •Blood donation within 4 weeks prior to screening, or stated intention to donate blood or blood products during the period of the study or within one month following completion of the study
• •Subjects who have participated in studies of an investigational drug or device within 30 days prior to the screening visit
• •Conditions preventing safe MRI imaging such as the subject's weight exceeding 500 lbs; maximum body dimension from side-to-side exceeding 70 cm and from back to front of torso exceeding 50 cm or the presence of metallic fragments, clips or devices
• •LVEF \<30% on the most recent assessment within 6 months
• •New York Heart Association (NYHA) Class IV or recent hospitalization for decompensated Heart Failure (HF) (\<3 months)
• •Unstable coronary syndromes
• •Moderate or severe aortic stenosis
• •Moderate or severe aortic regurgitation
• •Moderate or severe mitral stenosis
• •Moderate or severe mitral regurgitation