| Outcome Measures: |
Primary: 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., Baseline , Week 24 | Secondary: 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., 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., 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., 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., 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, Baseline , Week 24
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| Locations: |
Research Site, Hefei, Anhui, China|Research Site, Guangzhou, Guangdong, China|Research Site, Shi Jiazhuang, Hebei, China|Research Site, Ha'er Bing, Hei Longjiang, China|Research Site, Wuhan, Hu Bei, China|Research Site, Changsha, Hunan, China|Research Site, Nanjing, Jiangsu, China|Research Site, Changchun, Jilin, China|Research Site, Dalian, Liaoning, China|Research Site, Shenyang, Liaoning, China|Research Site, Shanghai, Shanghai, China|Research Site, Chengdu, Sichuan, China|Research Site, Hangzhou, Zhejiang, China|Research Site, Beijing, China|Research Site, Chongqing, China|Research Site, Tianjin, China|Research Site, Hyderabad, Andhra Pradesh, India|Research Site, Bangalore, Karnataka, India|Research Site, Mangalore, Karnataka, India|Research Site, Nagpur, Maharashtra, India|Research Site, Bangalore, India|Research Site, Seongnam, Gyeonggi-do, Korea, Republic of|Research Site, Bucheon, Korea, Republic of|Research Site, Daegu, Korea, Republic of|Research Site, Goyang, Korea, Republic of|Research Site, Gwangju, Korea, Republic of|Research Site, Incheon, Korea, Republic of|Research Site, Pusan, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Uijeongbu-si, Korea, Republic of
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