Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure - Full Text View

Sponsors and Collaborators:	VU University Medical Center Eli Lilly and Company
Information provided by:	VU University Medical Center
ClinicalTrials.gov Identifier:	NCT00766857

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Congestive Heart Failure	Drug: exenatide	Phase IV

MedlinePlus related topics: Diabetes Heart Failure

Drug Information available for: Insulin Exenatide Insulin glargine Dextrose Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure (NYHA II): a Randomized Comparator-Controlled Trial

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:

Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction). [ Time Frame: Week -2 and week 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Cardiac function, dimensions and scarring will be measured bij CMR [ Time Frame: week -2 and week 26 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Exercise capacity and performance will be assessed by a 6-minute walking test [ Time Frame: week -1 and week 27 ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Exenatide: Experimental	Drug: exenatide Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks). Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.
2. Insulin glargine: Active Comparator	Drug: exenatide Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks). Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Male and postmenopausal female
Age 40-70 years
Metformin therapy (stable, maximum tolerable dose for 2 months)
HbA1c 6.5-10%
Confirmed congestive heart failure (NHYA functional class II)
Ejection fraction < 40%
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766857

Contacts

Contact: Weena JY Chen, MD

+31-20-4442758

j.chen@vumc.nl

Locations

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

Sponsors and Collaborators

VU University Medical Center

Eli Lilly and Company

Investigators

Principal Investigator:

Michaela Diamant, MD, PhD

VUMC Diabetes Center

More Information

Responsible Party:	Diabetes Center VUMC ( Principal investigator: M. Diamant, MD, PhD )
Study ID Numbers:	DC2008exe001, EudraCT: 2008-005325-10
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766857
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:

Exenatide
Type 2 diabetes mellitus
Congestive heart failure
Incretin hormones

GLP-1 agonist
Cardiac metabolism
Insulin resistance
Cardiac MRI

Study placed in the following topic categories:

Heart Failure
Metabolic Diseases
Heart Diseases
Exenatide
Diabetes Mellitus
Endocrine System Diseases
Insulin

Glucagon-Like Peptide 1
Diabetes Mellitus, Type 2
Glargine
Insulin Resistance
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009