A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2017 |
| Start Date: | October 2012 |
| End Date: | September 2013 |
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
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.
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.
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 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
23
sites
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