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Table 1—

Baseline and week 24 mean A1C, FPG, proinsulin-to-insulin ratio, and HOMA-β and least-squares mean change from baseline to study end point with sitagliptin or placebo treatment

nWeek 0 (baseline) mean ± SDWeek 24 mean ± SDLeast-squares mean change from baseline (95% CI)
A1C (%)     
    Placebo 244 8.03 ± 0.82 8.20 ± 1.37 0.18 (0.06 to 0.30) 
    Sitagliptin 100 mg q.d. 229 8.01 ± 0.88 7.39 ± 1.15 −0.61 (−0.74 to −0.49)* 
    Sitagliptin 200 mg q.d. 238 8.08 ± 0.94 7.31 ± 1.14 −0.76 (−0.88 to −0.64)* 
FPG (mmol/l)     
    Placebo 247 9.8 ± 2.3 10.0 ± 3.1 0.3 (−0.0 to 0.5) 
    Sitagliptin 100 mg q.d. 234 9.5 ± 2.4 8.8 ± 2.5 −0.7 (−1.0 to −0.4)* 
    Sitagliptin 200 mg q.d. 244 9.7 ± 2.5 8.7 ± 2.6 −0.9 (−1.2 to −0.7)* 
Proinsulin-to-insulin ratio     
    Placebo 220 0.44 ± 0.30 0.44 ± 0.28 −0.01 (−0.04 to 0.02) 
    Sitagliptin 100 mg q.d. 210 0.47 ± 0.82 0.37 ± 0.25 −0.08 (−0.11 to −0.05) 
    Sitagliptin 200 mg q.d. 217 0.44 ± 0.48 0.34 ± 0.22 −0.11 (−0.14 to −0.07)* 
HOMA-β     
    Placebo 235 55.8 ± 52.1 56.3 ± 61.5 0.3 (−6.0 to 6.5) 
    Sitagliptin 100 mg q.d. 218 57.6 ± 71.7 70.9 ± 91.8 13.2 (6.7 to 19.7) 
    Sitagliptin 200 mg q.d. 228 55.2 ± 53.4 68.4 ± 66.3 13.1 (6.8 to 19.5) 
nWeek 0 (baseline) mean ± SDWeek 24 mean ± SDLeast-squares mean change from baseline (95% CI)
A1C (%)     
    Placebo 244 8.03 ± 0.82 8.20 ± 1.37 0.18 (0.06 to 0.30) 
    Sitagliptin 100 mg q.d. 229 8.01 ± 0.88 7.39 ± 1.15 −0.61 (−0.74 to −0.49)* 
    Sitagliptin 200 mg q.d. 238 8.08 ± 0.94 7.31 ± 1.14 −0.76 (−0.88 to −0.64)* 
FPG (mmol/l)     
    Placebo 247 9.8 ± 2.3 10.0 ± 3.1 0.3 (−0.0 to 0.5) 
    Sitagliptin 100 mg q.d. 234 9.5 ± 2.4 8.8 ± 2.5 −0.7 (−1.0 to −0.4)* 
    Sitagliptin 200 mg q.d. 244 9.7 ± 2.5 8.7 ± 2.6 −0.9 (−1.2 to −0.7)* 
Proinsulin-to-insulin ratio     
    Placebo 220 0.44 ± 0.30 0.44 ± 0.28 −0.01 (−0.04 to 0.02) 
    Sitagliptin 100 mg q.d. 210 0.47 ± 0.82 0.37 ± 0.25 −0.08 (−0.11 to −0.05) 
    Sitagliptin 200 mg q.d. 217 0.44 ± 0.48 0.34 ± 0.22 −0.11 (−0.14 to −0.07)* 
HOMA-β     
    Placebo 235 55.8 ± 52.1 56.3 ± 61.5 0.3 (−6.0 to 6.5) 
    Sitagliptin 100 mg q.d. 218 57.6 ± 71.7 70.9 ± 91.8 13.2 (6.7 to 19.7) 
    Sitagliptin 200 mg q.d. 228 55.2 ± 53.4 68.4 ± 66.3 13.1 (6.8 to 19.5) 
*

P ≤ 0.001 for least-squares mean difference for sitagliptin 100 or 200 mg vs. placebo;

P ≤ 0.01 for least-squares mean difference for sitagliptin 100 or 200 mg vs. placebo. P = NS for sitagliptin at 200- vs. 100-mg comparisons. (To convert glucose values from mmol/l to mg/dl, divide by 0.05551.)

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