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 (%)
    Placebo2448.03 ± 0.828.20 ± 1.370.18 (0.06 to 0.30)
    Sitagliptin 100 mg q.d.2298.01 ± 0.887.39 ± 1.15−0.61 (−0.74 to −0.49)*
    Sitagliptin 200 mg q.d.2388.08 ± 0.947.31 ± 1.14−0.76 (−0.88 to −0.64)*
FPG (mmol/l)
    Placebo2479.8 ± 2.310.0 ± 3.10.3 (−0.0 to 0.5)
    Sitagliptin 100 mg q.d.2349.5 ± 2.48.8 ± 2.5−0.7 (−1.0 to −0.4)*
    Sitagliptin 200 mg q.d.2449.7 ± 2.58.7 ± 2.6−0.9 (−1.2 to −0.7)*
Proinsulin-to-insulin ratio
    Placebo2200.44 ± 0.300.44 ± 0.28−0.01 (−0.04 to 0.02)
    Sitagliptin 100 mg q.d.2100.47 ± 0.820.37 ± 0.25−0.08 (−0.11 to −0.05)
    Sitagliptin 200 mg q.d.2170.44 ± 0.480.34 ± 0.22−0.11 (−0.14 to −0.07)*
HOMA-β
    Placebo23555.8 ± 52.156.3 ± 61.50.3 (−6.0 to 6.5)
    Sitagliptin 100 mg q.d.21857.6 ± 71.770.9 ± 91.813.2 (6.7 to 19.7)
    Sitagliptin 200 mg q.d.22855.2 ± 53.468.4 ± 66.313.1 (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.)