A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Diagnosis of diabetes mellitus type 2
• Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
• HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
• Fasting plasma glucose </=240 mg/dL at pre-randomization visit
• Agreement to maintain diet and exercise habits during the study

Exclusion Criteria:

• Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
• Any previous treatment with thiazolidinedione or a dual PPAR agonist
• Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
• Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening