A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

Inclusion criteria

• Adult patients, 30 to 70 years of age inclusive at screening
• Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
• HbA1c >/= 6.5% and </= 9% at screening and baseline
• Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
• Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
• Stable weight +/- 5% for at least 12 weeks prior to screening

Exclusion criteria

• Women who are pregnant, intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
• Diagnosis or history of type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
• Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
• Any previous treatment with a thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
• Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>/= 1 month) statin therapy
• History of bariatric surgery or currently undergoing evaluation for bariatric surgery
• Prior intolerance to fibrate
• Treatment with any anti-diabetic medication other than metformin in the last 12 weeks prior to screening and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
• Clinically apparent liver disease
• Positive for hepatitis B, hepatitis C or HIV infection
• Clinical evidence of anemia
• Symptomatic congestive heart failure (New York Heart Association Class II-IV) at screening
• Myocardial infarction, acute coronary syndrome, or transient ischemic attack/stroke within 6 months prior to screening
• Known macular edema at screening or prior to screening visit
• Uncontrolled hypertension despite stable (for at least 4 weeks) anti-hypertensive treatment
• Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
• Chronic oral or parenteral corticosteroid treatment (> 2 weeks) within 3 months prior to screening
• History of active substance abuse (including alcohol) within the past 2 years or positive test result for drugs of abuse or alcohol prior to first dosing
• Presence of any absolute or relative contraindication for the conduct of magnetic resonance imaging (MRI) investigation