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OpenTrials
Completed

NCT Number: NCT00766857

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Congestive Heart Failure Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VU University Medical Center

Amsterdam, North Holland, 1081, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

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

insulin glargine

Drug

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

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2008
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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