NCT00766857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2009

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

3.6 years

First QC Date

October 3, 2008

Last Update Submit

December 8, 2015

Conditions

Type 2 Diabetes MellitusCongestive Heart Failure

Keywords

ExenatideType 2 diabetes mellitusCongestive heart failureIncretin hormonesGLP-1 agonistCardiac metabolismInsulin resistanceCardiac MRI

Outcome Measures

Primary Outcomes (1)

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

    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

    week -2 and week 26

  • Cardiac function, dimensions and scarring will be measured bij CMR

    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.

    week -2 and week 26

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

    week -1 and week 27

Study Arms (2)

1. Exenatide

EXPERIMENTAL
Drug: exenatide

2. Insulin glargine

ACTIVE COMPARATOR
Drug: Insulin glargine

Interventions

exenatideDRUG

Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).

Also known as: exenatide-Byetta
1. Exenatide
Insulin glargineDRUG

Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.

Also known as: insulin glargine-Lantus
2. Insulin glargine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Type 1 diabetes mellitus
  • Serious renal or liver impairment
  • (Receiving treatment for) malignant disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28526033DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart FailureInsulin Resistance

Interventions

ExenatideInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Michaela Diamant, MD, PhD

    VUMC Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

May 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

NL(1)