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Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
This study has been completed.
Sponsor:
VU University Medical Center
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
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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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00766857
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):
| 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 September 21, 2017