Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Inclusion Criteria:

• Type 2 diabetes
• 18-78 years of age
• Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
• A1C: 7-10%
• C-peptide: ≥ 0.8 ng/mL
• Body mass index (BMI): ≤45 kg/m^2

Exclusion Criteria:

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Fasting plasma glucose (FPG) >270 mg/dL
• Significant cardiovascular history
• Symptoms of poorly controlled diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Insulin therapy within one year of screening
• Cardiovascular even within the prior 6 months
• New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
• Significant history of renal or hepatic disease
• History of a psychiatric disorder, alcohol or drug abuse within the previous year
• Treatment with potent CYP3A4 inhibitors or inducers
• Immunocompromised participants
• Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests