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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M. Diamant, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00766857
First received: October 3, 2008
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: M. Diamant, 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 13, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
 Exenatide
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013