Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes (EMPA-HEART)

This is an interventional diagnostic trial for Diabetes focused on measuring Cardiovascular Disease, Type 2 Diabetes, Cardiac Magnetic Resonance Imaging Read More

Inclusion Criteria:

• Male and female subjects ≥40 and ≤ 80 years of age
• History of type 2 diabetes
• Haemoglobin A1C ≥6.5 and ≤10 % within 3 months of the Screening Visit
• Established cardiovascular disease, defined as previous myocardial infarction ≥ 6 months ago, or previous coronary revascularization ≥ 2 months ago
• Any background antihyperglycemic therapy (which has been stable for at least 2 months)
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

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