A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

• Change in lipid profile [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
• Change from baseline in fasting plasma glucose [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
• Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
• Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
• Change from baseline in homeostatic index of beta cell function (HOMA-BCF) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
• Safety: incidence of adverse events [ Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up) ] [ Designated as safety issue: No ]

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. 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.

• Drug: aleglitazar
  150 mcg orally once a day for 26 weeks
• Drug: Placebo
  oral doses once a day for 26 weeks

• Experimental: aleglitazar
  Intervention: Drug: aleglitazar
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
• Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
• 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