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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).

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

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborators: Boehringer Ingelheim; Boehringer Ingelheim (Canada) LTD
• Treatments: Empagliflozin

Criteria

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