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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Congestive Heart Failure
• Interventions: Drug: exenatide; Drug: Insulin glargine

• Registration Number: NCT00766857
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Study Start: 2009-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Exenatide	exenatide	-
2. Insulin glargine	Insulin glargine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiac function, dimensions and scarring will be measured bij CMR	week -2 and week 26
Exercise capacity and performance will be assessed by a 6-minute walking test	week -1 and week 27
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
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

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands