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

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 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.

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 Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: aleglitazar+metformin
* Drug: placebo+metformin


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 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

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 |
| --- | --- |
| Experimental: aleglitazar<br> | Drug: aleglitazar+metformin<br>* 150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)<br>|
| Placebo Comparator: placebo<br> | Drug: placebo+metformin<br>* Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)<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 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) |