A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Mean Change From Baseline in Total Body Weight at Week 24

To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment

Time frame: Baseline and Week 24

Percentage of Subjects With Confirmed Hypoglycaemia at Week 24

Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)

Time frame: Baseline and Week 24

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24

To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

Time frame: Baseline and Week 24

Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24

To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

Time frame: Baseline and Week 24

Change From Baseline in the Mean Value of 24-hour Glucose at Week 2

Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.

Time frame: Baseline and Week 2