- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00799435
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction
Study Overview
Status
Intervention / Treatment
Detailed Description
Diastolic heart failure is a life-threatening condition that occurs when the ventricles of the heart become stiff and do not fully relax, preventing the heart from properly filling with blood. The circulation of blood then backs up, and blood collects in the body's organs, primarily the lungs. However, people with diastolic heart failure may have a normal ejection fraction, which is a measure of the amount of blood that the heart pumps out with each heart beat. Having type 2 diabetes may increase the risk of diastolic heart failure. Also, people with both heart failure and type 2 diabetes are more likely to experience poor health and even death than are people with only heart failure. It is possible that diabetes leads to increased stiffness of the ventricles and the aorta, which is the main blood vessel into which the heart empties. Exenatide, part of a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, is a new medication that is currently used to treat elevated blood sugar levels in people with diabetes. Some studies have shown that this class of medications may have a positive effect on the heart and blood vessels. The purpose of this study is to determine the effect that exenatide has on aortic and left ventricular stiffness in people who have type 2 diabetes and diastolic heart failure.
This 12-week study will enroll adults with type 2 diabetes and diastolic heart failure with normal ejection fraction. At a baseline study visit, participants will undergo a physical examination, blood pressure and heart rate measurements, a blood collection, an echocardiogram to obtain images of the heart, and a non-invasive test that measures blood flow in the aorta. Participants will then be randomly assigned to receive either exenatide or usual care. Participants who receive exenatide will inject the medicine twice a day for 12 weeks. At Week 4, these participants will attend a study visit to adjust the medication dosage and to report any problems, and at Week 6, study staff will follow up with participants by phone. All participants will attend a study visit at Week 12 for repeat baseline testing.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry
- Diagnosis of diastolic heart failure with a normal ejection fraction
- Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry
- Type 2 diabetes
Exclusion Criteria:
- Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry
- Angina with exertion
- Technically inadequate echocardiogram
- Atrial fibrillation or atrial flutter
- Severe valvular heart disease
- Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis)
- Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
- Significant history of active substance abuse
- Type 1 diabetes
- Type 2 diabetes requiring chronic insulin use before study entry
- Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure
- Pregnant or breastfeeding
- Hypertrophic cardiomyopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 1
Participants will receive usual care for 12 weeks.
The care will be dictated by the primary physician and/or diabetologist caring for the participant.
Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
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Experimental: 2
Participants will receive exenatide for 12 weeks.
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5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Time Frame: Measured at Week 12
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Measured at Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide
Time Frame: Measured at Week 12
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Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
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Measured at Week 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Aguilar, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Heart Failure
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Heart Failure, Diastolic
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Exenatide
Other Study ID Numbers
- 613
- 1K01HL092585 (U.S. NIH Grant/Contract)
- 1K01HL092585-01 (U.S. NIH Grant/Contract)
- H-22906 (Other Identifier: Baylor College of Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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