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

Amsterdam UMC, location VUmc27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Congestive Heart Failure

Interventions

exenatideDRUG

Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).

Insulin glargineDRUG

Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VU University Medical Center

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

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

Time frame: week -2 and week 11

Secondary Outcomes

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

Time frame: week -2 and week 26

Cardiac function, dimensions and scarring will be measured bij CMR

Time frame: week -2 and week 26

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.

Time frame: week -2 and week 26

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

Time frame: week -1 and week 27

Data from ClinicalTrials.gov

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