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
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Dapagliflozin; Sitagliptin; Placebo matching with Saxagliptin; Placebo matching with Dapagliflozin; Placebo matching with Sitagliptin
Intervention description: administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 461.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to
      metformin in combination with diet and exercise is superior to sitagliptin added to metformin
      in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26
      weeks.
    

Eligibility criteria:

        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