A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Enrollment
18
150 mcg orally daily, 6 weeks
orally daily, 6 weeks
Unnamed facility
Oxford, United Kingdom
Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
Time frame: from baseline to Week 6
Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)
Time frame: from baseline to Week 6
Change in cardiac/hepatic triglyceride content assessed my MRS
Time frame: from baseline to Week 6
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