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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

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