A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.
Inclusion Criteria:
Simsonville, South Carolina 29681, United States
Buenos Aires, Buenos Aires C1406FEQ, Argentina
Buenos Aires, Buenos Aires C1425AGC, Argentina
B. Rodolfo Teofilo, Ceará 60430, Brazil
Sao Paulo - Sp, São Paulo 04231, Brazil
Df, Mexico City 11800, Mexico
Tygerberg, Western Cape 7505, South Africa
Kyunggi-Do, 420-717, South Korea
Kyunggi-Do, 463-707, South Korea