Status:
COMPLETED
Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Type 2 Diabetes Mellitus
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 meta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00766857
Start Date
May 1 2009
End Date
December 1 2012
Last Update
December 9 2015
Active Locations (1)
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1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081