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

Condition(s) targeted: Type 2 Diabetes Mellitus; Congestive Heart Failure

Intervention: exenatide (Drug); Insulin glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: VU University Medical Center

Official(s) and/or principal investigator(s):
Michaela Diamant, MD, PhD, Principal Investigator, Affiliation: VUMC Diabetes Center

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).

Secondary outcome:

Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O

Cardiac function, dimensions and scarring will be measured bij CMR

Myocardial diastolic function parameters will be obtained bij trans thoracal echocardiography. Comparisons will be made of strain and torsion measures obtained bij CMR and echocardiography.

Exercise capacity and performance will be assessed by a 6-minute walking test

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

VU University Medical Center, Amsterdam, Noord-Holland 1081, Netherlands

Starting date: May 2009
Last updated: December 13, 2012