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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
197
150 mcg orally once a day for 26 weeks
oral doses once a day for 26 weeks
Unnamed facility
Chino, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Santa Ana, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Kissimmee, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Avon, Indiana, United States
Unnamed facility
Bethesda, Maryland, United States
...and 18 more locations
Change from baseline in hemoglobin HbA1c
Time frame: From baseline to week 26
Change in lipid profile
Time frame: From baseline to week 26
Change from baseline in fasting plasma glucose
Time frame: From baseline to week 26
Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)
Time frame: From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Time frame: From baseline to week 26
Change from baseline in markers of insulin sensitivity and cardiovascular risk
Time frame: From baseline to week 26
Safety: incidence of adverse events
Time frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
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