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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
oral doses once a day for 26 weeks
150 mcg orally once a day for 26 weeks
Unnamed facility
Chino, California, United States
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 A1c (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 homeostatic index of beta cell function (HOMA-BCF)
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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Unnamed facility
Los Angeles, California, United States
Unnamed facility
Santa Ana, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
Unnamed facility
West Hills, California, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
Cooper City, Florida, United States
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
...and 24 more locations