Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Inclusion Criteria:

• ≥18- and ≤77-years-old
• Type 2 diabetes
• Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
• Glycosylated hemoglobin (A1C) ≥7% and ≤10%
• Body mass index (BMI) ≤40 kg/m2

Exclusion Criteria:

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Significant cardiovascular history
• Active liver disease
• Renal impairment