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

December 8, 2015 updated by: M.H.H. Kramer, Amsterdam UMC, location VUmc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Exenatide
Drug: exenatide
Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
Other Names:
  • exenatide-Byetta
Active Comparator: 2. Insulin glargine
Drug: 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 Names:
  • insulin glargine-Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
Time Frame: week -2 and week 11
week -2 and week 11

Secondary Outcome Measures

Outcome Measure
Time Frame
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
week -2 and week 26
Cardiac function, dimensions and scarring will be measured bij CMR
Time Frame: week -2 and week 26
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
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
week -1 and week 27

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Michaela Diamant, MD, PhD, VUMC Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC2008exe001
  • EudraCT: 2008-005325-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on exenatide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe