The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
282
5mg oral tablet once daily
500mg oral tablet once daily
750mg, 2 tablets once daily
Change in HbA1c Level From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized 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 to week 18
Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG 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 to week 18
Change in FPG From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG 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 to week 18
Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
Percent of subjects achieving therapeutic response (HbA1c \<7.0%) at Week 18 (LOCF) (Randomized analysis set)
Time frame: Week 18 (LOCF)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Jonesboro, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Los Angeles, California, United States
Research Site
Pasadena, California, United States
Research Site
Sacramento, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Wellington, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
...and 25 more locations