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
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | December 2012 |
| End Date: | September 2013 |
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
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.
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.
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 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)
- 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
We found this trial at
16
sites
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