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 |
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.
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
We found this trial at
24
sites
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