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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:November 2012
End Date:September 2013

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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

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.


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 pre-randomization visit

- Fasting plasma glucose
- 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
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