Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial

The purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.

Inclusion Criteria:

• Type 2 diabetes mellitus
• Male and postmenopausal female
• Age 18 years an above
• Metformin therapy (stable, maximum tolerable dose for 2 months)
• HbA1c 6.5-10%
• Confirmed congestive heart failure (NHYA functional class II-IV)
• Ejection fraction < 50%
• Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study

Exclusion Criteria:

• Type 1 diabetes mellitus
• Serious renal or liver impairment
• (Receiving treatment for) malignant disease
• Cardiovascular event < 3 months prior to inclusion
• Acute congestive heart failure
• Any reason for not being able to sustain the imaging studies
• Pacemaker/ICD
• Contraindications for the use of exenatide/ insulin
• Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening
• Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (> 2 weeks) within 2 weeks immediately prior to screening