The effects of sitagliptin (Januvia) on myocardial performance in patients with coronary artery disease and diabetes
- Conditions
- coronary artery disease and type 2 diabetes mellitusMedDRA version: 9.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disordersMedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent
- Registration Number
- EUCTR2008-000300-89-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Normal resting left ventricular function
Symptomatic coronary artery disease
Type 2 diabetes or impaired fasting glucose
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
resting LV dysfunction
a history of myocardial infarction within the preceding 3 months
significant myocardial hypertrophy, valve disease or conduction abnormality
a pacemaker
renal impairment (serum creatinine > 175 µmol/l)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We propose that in patients with insulin resistance (independent of type 2 diabetes mellitus) and coronary disease, sitagliptin will promote myocardial glucose utilisation and protect the heart against post-ischaemic left ventricular dysfunction and improve the myocardial response to dobutamine stress.;Secondary Objective: ;Primary end point(s): Left ventricular ejection fraction during dobutamine stress echocardiography<br>Tissue Doppler LV velocities during dobutamine stress echocardiography
- Secondary Outcome Measures
Name Time Method