A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin 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 compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin 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 ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION THERAPY

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: aleglitazar
* Drug: placebo


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 sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy 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) Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aleglitazar<br> | Drug: aleglitazar<br>* 150 mcg orally once a day for 26 weeks<br>|
| Experimental: placebo<br> | Drug: placebo<br>* oral doses 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 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 markers of insulin sensitivity and cardiovascular risk |  | From baseline to week 26 | 
| Safety: incidence of adverse events |  | 30 weeks (26 weeks treatment and 4 weeks follow-up) |