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.
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina