Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control,
defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 %
obtained at the screening visit

- Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at
least 8 weeks prior to the enrollment visit and with no intake of other
antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks
prior to screening

- BMI > 20.0 kg/m2 at the enrollment visit

- Males and Females, age ≥18 years old at time of screening visit

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
the start of study drug

- Women must not be breastfeeding

Exclusion Criteria:

- Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes
of Young (MODY), secondary diabetes mellitus or diabetes insipidus

- History of diabetic ketoacidosis

- Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the
enrollment visit

- Myocardial infarction

- Cardiac surgery or revascularization (coronary artery bypass surgery Coronary
Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty
percutaneous transluminal coronary angioplasty [(PTCA)])

- Unstable angina

- Unstable congestive heart failure (CHF)

- Transient ischemic attack (TIA) or significant cerebrovascular disease

- Unstable or previously undiagnosed arrhythmia

- Congestive heart failure, defined as New York Heart Association (NYHA) Class III
and IV, unstable or acute congestive heart failure and/or known left ventricular
ejection fraction of ≤ 40%

- Renal Disease

- Hepatic Diseases

- Hematological and Oncological Disease/Conditions

- Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women

- Abnormal Free T4