Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability
The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
368
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Buenos Aires, Argentina
Sanofi-Aventis
Lane Cove, Australia
Sanofi-Aventis
Laval, Canada
Absolute change in HbA1C from baseline to Week 48
Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
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Sanofi-Aventis
Providencia, Chile
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Milan, Italy
Sanofi-Aventis
Gouda, Netherlands
Sanofi-Aventis
Moscow, Russia
...and 2 more locations