A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Phase 3

Completed

Brief Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.

Recruitment & Eligibility

Inclusion Criteria

Adult patient, >/= 18 years of age
Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening
Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time 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 </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study

Exclusion Criteria

Pregnant women, women 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:
1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
Any previous treatment with 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
Prior intolerance to fibrate
Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
Clinically apparent liver disease
Anemia at or within 4 weeks prior to screening
Inadequate renal function
Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening
Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
Known macular edema at screening or prior to screening visit
Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
Uncontrolled hypertension
History of active substance abuse (including alcohol) within the past 2 years

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Aleglitazar	aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from baseline to Week 26

Secondary Outcome Measures

Name	Time	Method
Change in lipids	from baseline to Week 26
Change in fasting plasma glucose (FPG)	from baseline to Week 26
Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26	26 weeks
Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])	from baseline to Week 26
Change in homeostatic index of beta cell function (by HOMA-BFC)	from baseline to Week 26
Change in markers of insulin sensitivity/cardiovascular risk	from baseline to Week 26
Safety: Incidence of adverse events	approximately 30 weeks