Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
Primary Purpose
Type 2 Diabetes Mellitus, Congestive Heart Failure
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
exenatide
Insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Exenatide, Type 2 diabetes mellitus, Congestive heart failure, Incretin hormones, GLP-1 agonist, Cardiac metabolism, Insulin resistance, Cardiac MRI
Eligibility 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
Sites / Locations
- VU University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Exenatide
2. Insulin glargine
Arm Description
Outcomes
Primary Outcome Measures
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
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
Cardiac function, dimensions and scarring will be measured bij CMR
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.
Exercise capacity and performance will be assessed by a 6-minute walking test
Full Information
NCT ID
NCT00766857
First Posted
October 3, 2008
Last Updated
December 8, 2015
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT00766857
Brief Title
Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 metabolism leading to improvement of cardiac efficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Congestive Heart Failure
Keywords
Exenatide, Type 2 diabetes mellitus, Congestive heart failure, Incretin hormones, GLP-1 agonist, Cardiac metabolism, Insulin resistance, Cardiac MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Exenatide
Arm Type
Experimental
Arm Title
2. Insulin glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
exenatide-Byetta
Intervention Description
Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
insulin glargine-Lantus
Intervention Description
Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.
Primary Outcome Measure Information:
Title
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
Time Frame
week -2 and week 11
Secondary Outcome Measure Information:
Title
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
Title
Cardiac function, dimensions and scarring will be measured bij CMR
Time Frame
week -2 and week 26
Title
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
Title
Exercise capacity and performance will be assessed by a 6-minute walking test
Time Frame
week -1 and week 27
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Diamant, MD, PhD
Organizational Affiliation
VUMC Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
28526033
Citation
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.
Results Reference
derived
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Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
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