Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
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ClinicalTrials.gov Identifier: NCT00766857 |
Recruitment Status :
Completed
First Posted : October 6, 2008
Last Update Posted : December 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Congestive Heart Failure | Drug: exenatide Drug: Insulin glargine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
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 |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction). [ Time Frame: week -2 and week 11 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Netherlands | |
VU University Medical Center | |
Amsterdam, Noord-Holland, Netherlands, 1081 |
Principal Investigator: | Michaela Diamant, MD, PhD | VUMC Diabetes Center |
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 Posted: | October 6, 2008 Key Record Dates |
Last Update Posted: | December 9, 2015 |
Last Verified: | December 2015 |
Exenatide Type 2 diabetes mellitus Congestive heart failure Incretin hormones |
GLP-1 agonist Cardiac metabolism Insulin resistance Cardiac MRI |
Heart Failure Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Heart Diseases Cardiovascular Diseases Insulin |
Insulin, Globin Zinc Insulin Glargine Exenatide Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |