Date

2015-10-29

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

01. Subjects between the age of 10 to 17 years on day of signing informed consent with randomization to occur prior to 18th birthday. 02. Diagnosed Type 2 Diabetes Mellitus (T2DM) 03.Has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1. 04.HbA1C greater than or equal to 6.5% and less than or equal to 10.0% on metformin, greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. (Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated). 05. Participant has a family member or adult closely involved in the daily activities.

Next Version

01. Subjects between the age of 10 to 17 years on day of signing informed consent with randomization to occur prior to 18th birthday. 02. Diagnosed Type 2 Diabetes Mellitus (T2DM) 03. Patient on metformin monotherapy (?1500 mg/day, for ?12 weeks) with A1C ?6.5% and ?10.0% OR Patients is on stable doses of metformin (?1500 mg/day, for ?12 weeks) and insulin (of any type, variance in dose to be ?15% of total daily dose for ?12 weeks prior to Screening Visit/ Visit 1) with an A1C?7.0% and 10%. 04.HbA1C greater than or equal to 6.5% and less than or equal to 10.0% on metformin, greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. (Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated). 05. Participant has a family member or adult closely involved in the daily activities.