Date

2015-10-29

Protocol

Protocol changed

Item Changed

What is the research question being addressed?

Previous Version

Is MK-0431A (fixed-dose combination tablet of sitagliptin and metformin) more effective and safer than metformin alone for the treatment of T2DM in patients aged 10-17 years failing metformin monotherapy?

Next Version

Is MK0431A (fixed-dose combination tablet of sitagliptin and metformin) more effective and safer to achieve glycemic control for the treatment of T2DM in patients aged 10-17 who are on metformin monotherapy or in combination with insulin) and does the addition of sitagliptin reduce hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment?