Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
570
Oral tablet, once daily for 24 weeks
oral tablet, once daily for 24 weeks
oral tablet, once daily for 24 weeks
Research Site
Hefei, Anhui, China
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline HbA1c.
Time frame: Baseline , Week 24
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.
Time frame: Baseline , Week 24
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.
Time frame: Baseline , Week 24
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.
Time frame: Baseline , Week 24
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Research Site
Beijing, China, China
Research Site
Chongqing, China, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Ha'er Bing, Hei Longjiang, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
...and 20 more locations
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.
Time frame: Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response
Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c \< 7.0% for saxagliptin + metformin versus placebo + metformin at week 24
Time frame: Baseline , Week 24