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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.H.H. Kramer, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00766857
First received: October 3, 2008
Last updated: December 8, 2015
Last verified: December 2015
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   (Adult, Senior)
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
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

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
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
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 September 29, 2016