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

Amsterdam UMC, location VUmc

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Congestive Heart Failure

Treatments

Drug: exenatide

Drug: Insulin glargine

Study type

Interventional

Funder types

Other

Identifiers

NCT00766857

DC2008exe001

EudraCT: 2008-005325-10

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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