Saxagliptin 2.5 mg (n=247) Saxagliptin 5 mg (n=643) Placebo (n=559) Age , y 54.2 (10.4) 52.1 (10.3) 51.9 (10.8) <65 y, n (%) 208 (84.2) 576 (89.6) 490 (87.7) Sex, n (%)       Women 127 (51.4) 301 (46.8) 259 (46.3) Race, n (%)       White 193 (78.1) 190 (29.5) 132 (23.6) Asian 37 (15.0) 431 (67.0) 410 (73.3) Black 12 (4.9) 18 (2.8) 10 (1.8) Other 5 (2.0) 4 (0.6) 7 (1.3) Weight, kg 87.7 (17.9) 76.2 (17.5) 74.7 (15.5) BMI , kg/m2 31.1 (4.8) 28.1 (4.9) 27.7 (4.6) Duration of T2DM , y 2.2 (3.0) 1.3 (2.6) 1.4 (2.5) HbA1c % 8.0 (1.0) 8.1 (0.9) 8.1 (0.9) HbA1c category , n (%)       <8.0% 138 (55.9) 306 (47.6) 271 (48.5) 8.0–<9.0% 66 (26.7) 221 (34.4) 187 (33.5) ≥9.0% 43 (17.4) 116 (18.0) 101 (18.1) FPG, mg/dL 169.9 (43.2) 162.8 (39.4) 162.0 (43.9) PPG 2-h AUC (SD), mg∙min/dL 47470.0 (11687.7) 46743.1 (10835.3) 47209.6 (11917.3) Fasting insulin (SD), pmol/L 15.4 (10.2) 13.2 (13.7) 11.8 (9.4) Creatinine clearance, mL/min 116.0 (37.9) 107.1 (35.1) 106.1 (36.1)

AUC=area under the curve; BMI=body mass index; FPG=fasting plasma glucose; HbA1c=glycated hemoglobin; PPG=postprandial glucose; T2DM=type 2 diabetes mellitus. Values are mean (SD) unless otherwise indicated. *Safety population includes saxagliptin 2.5- to 5-mg titration group data pooled with 2.5-mg groups, data for 5-mg PM group pooled with 5-mg AM groups, and data pooled for placebo groups. Efficacy population includes pooled data for saxagliptin 2.5-mg groups (not including 2.5- to 5-mg titration group) , saxagliptin 5-mg AM groups, and placebo groups.

Table 1: Patient Baseline Demographics and Disease Characteristics, Pooled Safety Population*.