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Table 1. Summary of sitagliptin phase III clinical data.

Monotherapy/ Total Duration Sitagliptin dose Baseline Change in
combination number of HbA 1c HbA 1c
patients (weeks) (%) (%)
Monotherapy 23 555 12 50 mg bid or 100 mg QD 7.7 -0.39 to -0.56*
Monotherapy 24 743 12 5, 12.5, 25 or 50 mg BID 7.9 -0.38 to -0.77*
Monotherapy 25 521 18 100 mg or 200 mb QD 8.1 -0.48 to -0.60*
Monotherapy 26 741 24 100 mg or 200 mb QD 8.0 -0.79 to -0.94*
Monotherapy 27 1172 52 100 mg QD 7.5 -0.67
Metformin 28 273 18 100 mg QD 7.7 -0.73
Metformin 29 701 24 100 mg QD 8.0 -0.65*
Metformin 30 1091 24 100 mg QD 8.8 -1−2.1
(initial combination study)
Metformin 27 1172 52 100 mg QD 7.5 -0.67
Metformin 31 587 104 100 mg QD 8.6 -1.4 to -1.7
(initial combination study)
Thiazolidinedione 353 24 100 mg QD 8.1 -0.70*
(TZD) 32
Sulphonylurea (SU) 33 441 24 100 mg QD 8.3 -0.74*
Metformin + SU 33 222 24 100 mg QD 8.3 -0.89*
Metformin + TZD 34 277 18 100 mg QD 8.8 -0.9
*Placebo-adjusted change. Note that the studies are different and therefore not comparable; doses may vary in different
studies. Change in HbA 1c shows change from baseline except when asterisk is shown. QD = once daily dosing; BID = twice
daily dosing

Table 2. Summary of vildagliptin phase III clinical data.

Monotherapy/ Total Duration Vildagliptin dose Baseline Change in
combination number of HbA 1c HbA
1c
patients (weeks) (%) (%)
Monotherapy 35 37 4 50 mg BID 7.2 -0.38*
Monotherapy 36 98 12 25 mg QD 8.0 -0.6*
Monotherapy 37 354 24 50 mg QD, 50 mg BID 8.4 -0.5 to -0.9*
or 100 QD
50 mg QD, 50 mg BID
Monotherapy 38 632 24 8.4 -0.8 to -0.9
or 100 QD
Monotherapy 39 786 24 50 mg BID 8.7 -1.1
Monotherapy 40 131 52 50 mg QD 6.6 -0.30
Metformin 41 544 24 50 mg QD or 50 BID 8.4 -0.7 to -1.1
Metformin 42 576 24 50 mg BID 8.4 -0.9
Metformin 43 107 52 50 mg QD 7.8 -1.1
Metformin 44 2789 52 50 mg BID 7.3 -0.44
TZD 45 463 24 50 mg QD or 50 BID 8.7 -0.8 to -1.1*
SU 46 515 24 50 mg QD or 50 BID 8.5 -0.6 to -0.7*
*Placebo-adjusted change. Note that the studies are different and therefore not comparable; doses may vary in different
studies. Change in HbA 1c shows change from baseline except when asterisk is shown. QD = once daily dosing; BID = twice
daily dosing.
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