Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
822
tablet, per oral, once daily
capsule, per oral, once daily
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Time frame: Baseline, Week 18
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set)
Time frame: Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Time frame: Baseline, Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Time frame: Baseline, Week 18 (Last Observation Carried Forward)
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Research Site
Buenos Aires, Buenos Aires, Argentina
Research Site
Lanus, Buenos Aires, Argentina
Research Site
Mar del Plata, Buenos Aires, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
Caba, Argentina
Research Site
Capital Federal, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Research Site
Rosario, Argentina
Research Site
Aalst, Belgium, Belgium
...and 77 more locations