A Study of Aleglitazar in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
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A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Actos
* Drug: Placebo
* Drug: aleglitazar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes, diagnosed >=1 month of screening; either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses; HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit. Exclusion Criteria: type 1 diabetes; currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist; clinically significant cardiovascular disease; Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Actos<br> | Drug: Actos<br>* 45mg po daily<br>|
| Experimental: Aleglitazar 1<br> | Drug: aleglitazar<br>* Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.<br>|
| Experimental: Aleglitazar 2<br> | Drug: aleglitazar<br>* Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.<br>|
| Experimental: Aleglitazar 3<br> | Drug: aleglitazar<br>* Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.<br>|
| Experimental: Aleglitazar 4<br> | Drug: aleglitazar<br>* Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in Hemoglobin A1c (HbA1c) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers. |  | 16 weeks | 
| Adverse Events (AEs), laboratory parameters. |  | Throughout study |