The effect of exenatide compared to insulin glargine on cardiac function and metabolism in type 2 diabetic patients with congestive heart failure (NYHA II): a randomized-controlled trial

• Conditions: Cardiac function and metabolism in type 2 diabetic patients with congestive heart failure; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10010684Term: Congestive heart failure

• Registration Number: EUCTR2008-005325-10-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

type 2 diabetic patients
age 40-70 years
metformin therapy
HbA1 6.5 - 10%
Congestive heart failure (NYHA II)
Ejection fraction <40 %
Stable standard therapy for their cardiac condition
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

type 1 diabetes mellitus
serious renal or liver impairment
malignant disease
cardiovascular event < 3 months prior to inclusion
contraindications for CMR
Use of insulin, thiazolidinediones, incretin-based therapies (within 4 months of screening), glucocorticoids, NSAIDs or centrally acting drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified