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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766857
First Posted: October 6, 2008
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.H.H. Kramer, VU University Medical Center
  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: 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

Resource links provided by NLM:


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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
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 Submitted: October 3, 2008
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