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

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 Drug: Insulin glargine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Insulin Insulin human Exenatide Insulin glargine

U.S. FDA Resources

Further study details as provided by M.H.H. Kramer, 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 ]

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 ]
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 ]


Enrollment:	27
Study Start Date:	May 2009
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Study First Received:	October 3, 2008
Last Updated:	December 8, 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

ClinicalTrials.gov processed this record on July 27, 2017