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Trial · Interventional

CompletedPhase 4Registry data

Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

NCTNCT00766857 (opens ClinicalTrials.gov in a new tab)Other idDC2008exe001Other idEudraCT: 2008-005325-10
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
27 participants (actual)
Sponsor
Amsterdam UMC, location VUmc · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
May 2009
Primary completion
Dec 2012
Completion
Dec 2012
First posted
6 Oct 2008 (estimated)
Last update posted
9 Dec 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus · Congestive Heart Failure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 4

    Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

    NCT00766857

    May 2009 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • Insulin glargineDrug

Arms2

  • Experimental

    1. Exenatide

  • Active comparator

    2. Insulin glargine

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).

    Time frame · week -2 and week 11

Secondary outcomes(4)

  1. 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

  2. Cardiac function, dimensions and scarring will be measured bij CMR

    Time frame · week -2 and week 26

  3. 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

  4. Exercise capacity and performance will be assessed by a 6-minute walking test

    Time frame · week -1 and week 27

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

4 results

Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine.

Chen et al. 2017Cardiovascular diabetologycited by 21

PMID 28526033PMC5438489DOI 10.1186/s12933-017-0549-zPUB-28526033

CC BY4 results
Download PDFSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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