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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766857
• Other study ID #: DC2008exe001
• Secondary ID: EudraCT: 2008-00
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2008
• Last updated: December 8, 2015
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).		week -2 and week 11	No
Secondary	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	No
Secondary	Cardiac function, dimensions and scarring will be measured bij CMR		week -2 and week 26	No
Secondary	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	No
Secondary	Exercise capacity and performance will be assessed by a 6-minute walking test		week -1 and week 27	No