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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: aleglitazar


Participation Criteria
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Eligibility Criteria
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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 peroxisome proliferator activated receptor (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral doses once a day for 26 weeks<br>|
| Experimental: aleglitazar<br> | Drug: aleglitazar<br>* 150 mcg orally once a day for 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin HbA1c |  | From baseline to week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid profile |  | From baseline to week 26 | 
| Change from baseline in fasting plasma glucose |  | From baseline to week 26 | 
| Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%) |  | From baseline to week 26 | 
| Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) |  | From baseline to week 26 | 
| Change from baseline in homeostatic index of beta cell function (HOMA-BCF) |  | From baseline to week 26 | 
| Safety: incidence of adverse events |  | 30 weeks (26 weeks treatment and 4 weeks follow-up) |