Type 2 Diabetes MellitusPhase 4NCT00766857
Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
A Phase 4 study testing exenatide and Insulin glargine in people with Type 2 Diabetes Mellitus and Congestive Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Congestive Heart Failure
- What is being tested?
- exenatide and Insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus, Congestive Heart Failure
- Being tested
- exenatide, Insulin glargine
- Keywords
- Exenatide, Type 2 diabetes mellitus, Congestive heart failure, Incretin hormones, GLP-1 agonist, Cardiac metabolism, Insulin resistance, Cardiac MRI
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
Also called exenatide-Byetta
Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
Insulin glargineDrug
Also called insulin glargine-Lantus
Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Exenatide | Experimental | Not described Receives: Drug: exenatide |
| 2. Insulin glargine | Active comparator | Not described Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
Measured: week -2 and week 11
Secondary outcomes (4)
Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O
Measured: week -2 and week 26
Cardiac function, dimensions and scarring will be measured bij CMR
Measured: 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.
Measured: week -2 and week 26
Exercise capacity and performance will be assessed by a 6-minute walking test
Measured: week -1 and week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.H.H. Kramer, Amsterdam UMC, location VUmc
- Investigators
- Michaela Diamant, MD, PhD, Principal investigator, VUMC Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766857
- Sponsor's protocol ID
- DC2008exe001
- Other IDs
- EudraCT: 2008-005325-10
- Status last verified
- Dec 2015
- First submitted
- 3 Oct 2008
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28526033
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00766857
- Acronym / sponsor ID
- DC2008exe001
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Exenatide | Experimental | Drug: exenatide |
| 2. Insulin glargine | Active comparator | Drug: Insulin glargine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatideAlso: exenatide-ByettaExenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks). | Drug | 1. Exenatide |
| Insulin glargineAlso: insulin glargine-LantusInsulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance. | Drug | 2. Insulin glargine |
Primary outcome
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
Time frame: week -2 and week 11
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 28526033Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Diamant, MD, PhD principal investigator
VUMC Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exenatide and Insulin glargine in people with Type 2 Diabetes Mellitus and Congestive Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction). (time frame: week -2 and week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.