Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
NCT ID: NCT00766857
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2009-05-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. Exenatide
exenatide
Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
2. Insulin glargine
Insulin glargine
Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.
Interventions
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exenatide
Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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M.H.H. Kramer
MD, PhD
Principal Investigators
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Michaela Diamant, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
VUMC Diabetes Center
Locations
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VU University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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References
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Chen WJY, Diamant M, de Boer K, Harms HJ, Robbers LFHJ, van Rossum AC, Kramer MHH, Lammertsma AA, Knaapen P. Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine. Cardiovasc Diabetol. 2017 May 19;16(1):67. doi: 10.1186/s12933-017-0549-z.
Other Identifiers
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EudraCT: 2008-005325-10
Identifier Type: -
Identifier Source: secondary_id
DC2008exe001
Identifier Type: -
Identifier Source: org_study_id