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Table 2 Changes in glycemic parameters from baseline to week 24 (LOCF)

From: The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naïve patients with type 2 diabetes mellitus: a randomized controlled trial

  SAXA 2.5 mg q.A.M. (n = 74) SAXA 5 mg q.A.M. (n = 74) SAXA 2.5/5 mg q.A.M. (n = 71) SAXA 5 mg q.P.M. (n = 72) Placebo (n = 74)
HbA 1c (%)      
n 67 69 69 70 68
BL, mean (SE) 8.0 (0.11) 7.9 (0.11) 8.0 (0.13) 7.9 (0.11) 7.8 (0.11)
Week 24 mean (SE) 7.3 (0.11) 7.3 (0.13) 7.4 (0.14) 7.3 (0.12) 7.6 (0.14)
Adj change from BL, mean (SE) −0.71 (0.103) −0.66 (0.102) −0.63 (0.102) −0.61 (0.101) −0.26 (0.103)
Difference from placebo (SE) −0.45 (0.146) −0.40 (0.145) −0.37 (0.145) −0.35 (0.144)  
P-value vs placebo 0.002* 0.006* 0.012* 0.016*  
FPG (mg/dL)      
n 70 71 71 71 71
BL, mean (SE) 157 (4.0) 162 (4.2) 171 (6.2) 160 (5.3) 159 (5.4)
Week 24 mean (SE) 147 (3.8) 151 (5.9) 155 (5.9) 152 (5.9) 163 (6.3)
Adj change from BL, mean (SE) −11 (4.5) −11 (4.5) −13 (4.5) −8 (4.5) 3 (4.5)
Difference from placebo (SE) −15 (6.3) −14 (6.3) −16 (6.3) −11 (6.3)  
P-value vs placebo 0.020* 0.027* 0.013* 0.076  
Patients achieving HbA 1c <7% (%) 35.8 44.9 43.5 38.6 35.3
Difference from placebo (%) 0.5 9.6 8.2 3.3  
P-value vs placebo 1.0000 0.2968 0.3832  
PPG–AUC (mg·min/dL)      
n 48 48 47 43 47
BL, mean (SE) 47432 (1496.6) 50417 (1561.5) 50032 (1684.7) 47078 (1941.9) 47640 (1759.7)
Week 24 mean (SE) 39798 (1347.0) 41562 (1489.3) 41745 (1739.2) 41530 (1962.7) 44861 (1854.7)
Adj change from BL, mean (SE) −8014 (1246.9) −8218 (1249.1) −7781 (1261.0) −6048 (1318.2) −3088 (1259.7)
Difference from placebo (SE) −4927 (1771.1) −5130 (1776.4) −4694 (1784.3) −2961 (1821.5)  
P-value vs placebo  
  1. Randomized patients data set.
  2. *Statistically significant at prespecified level.
  3. P-values only presented when permitted by sequential testing procedure.
  4. Adj: adjusted; BL: baseline; FPG: fasting plasma glucose; HbA1c: glycated hemoglobin; PPG-AUC: postprandial glucose–area under the curve; SAXA: saxagliptin; SE: standard error.