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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Congestive Heart Failure	Drug: exenatide; Drug: Insulin glargine	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	May 2009
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1. Exenatide	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).; Other Name: exenatide-Byetta
Active Comparator: 2. Insulin glargine	Drug: Insulin glargine; Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.; Other Name: insulin glargine-Lantus

Outcome Measures

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Primary Outcome Measures :

1. Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction). [ Time Frame: week -2 and week 11 ]

Secondary Outcome Measures :

1. 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 ]
2. Cardiac function, dimensions and scarring will be measured bij CMR [ Time Frame: week -2 and week 26 ]
3. 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 ]
4. Exercise capacity and performance will be assessed by a 6-minute walking test [ Time Frame: week -1 and week 27 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

VU University Medical Center

Investigators

Principal Investigator:	Michaela Diamant, MD, PhD	VUMC Diabetes Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen WJY, Diamant M, de Boer K, Harms HJ, Robbers LFHJ, van Rossum AC, Kramer MHH, Lammertsma AA, Knaapen P. Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine. Cardiovasc Diabetol. 2017 May 19;16(1):67. doi: 10.1186/s12933-017-0549-z.

Responsible Party:	M.H.H. Kramer, MD, PhD, VU University Medical Center
ClinicalTrials.gov Identifier:	NCT00766857 History of Changes
Other Study ID Numbers:	DC2008exe001; EudraCT: 2008-005325-10
First Posted:	October 6, 2008
Last Update Posted:	December 9, 2015
Last Verified:	December 2015

Keywords provided by M.H.H. Kramer, VU University Medical Center:

Exenatide; Type 2 diabetes mellitus; Congestive heart failure; Incretin hormones	GLP-1 agonist; Cardiac metabolism; Insulin resistance; Cardiac MRI

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Heart Failure; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Insulin, Globin Zinc	Exenatide; Insulin; Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists