Vildagliptin | place in therapy review Table 4 | Effects of vildagliptin on blood glucose and glycosylated hemoglobin (HbA1c) in placebo-controlled studies (all level 2 evidence) V 50 mg bid (n=84) V 50 mg qd –0.5 V 50 mg qd 25%c V 50 mg qd –0.5 % patients reaching HbA1c <7.0%a Placebo + M ≥1.5 g 9.4% NR V 100 mg qd + M ≥1.5 g 35.5% (P<0.001 vs placebo) NR NR NR NR NR NR NR NR NR NR NR NR Placebo 13.6% Placebo +0.1 V 50 mg bid 30.4% (P<0.01 vs placebo) V 50 mg bid –1.2 (P<0.001 vs placebo) V 100 mg qd 39.1% (P<0.001 vs placebo) Outcome Reference Mean change from baseline in fasting plasma glucose (mmol/L) Mean change from baseline in 4 h-postprandial plasma glucose (mmol/L) NR NR NR Placebo –0.1 V 50 mg qd –1.0 V 50 mg bid –0.8 V 100 mg qd –0.8 Greater decrease with V than with placebo at (P=0.118)c NR V 100 mg qd –1.1 (P<0.001 vs placebo) Placebo + I >30 U/day –0.8 V 50 mg bid + I >30 U/day –0.2 Placebo +0.13 V 10 mg bid –0.62 V 25 mg bid –0.78 V 50 mg bid –1.37 (all P<0.001 vs placebo) NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR Placebo +0.2d V 10 mg bid –3.5d V 25 mg bid –3.2d V 50 mg bid –3.4d (all P<0.001 vs placebo) Design Treatment and dose Double-blind, placebo-controlled RCT, 24 weeks Placebo + M ≥1.5 g (n=130) V 50 mg qd + M ≥1.5 g (n=143) V 100 mg qd + M ≥1.5 g (n=143) Double-blind, placebo-controlled RCT, 24 weeks Placebo (n=94) Placebo –0.3 V 50 mg qd (n=104) V 50 mg qd –0.8 Double-blind, placebo-controlled RCT, 24 weeks Double-blind, placebo-controlled RCT, 24 weeks Double-blind, placebo-controlled RCT, 24 weeks Double-blind, placebo-controlled RCT, 12 weeks continued overleaf... Core Evidence 2008;3(1) Mean change from baseline in HbA1c (percentage points) Placebo + M ≥1.5 g +0.2 V 50 mg qd + M ≥1.5 g –0.5 (P<0.001 vs placebo) V 100 mg qd + M ≥1.5 g –0.9 (P<0.001 vs placebo) (all P<0.01 vs placebo) V 50 mg qd or bid + G 4 mg qd –0.7b (P<0.001 vs placebo) Placebo 0 V 50 mg bid –0.7 (P<0.001 vs placebo) V 100 mg qd –0.8 (P<0.001 vs placebo) Placebo + I >30 U/day –0.2 V 50 mg bid + I >30 U/day –0.5 (P=0.01 vs placebo) (all P<0.001 vs placebo) V 50 mg bid (n=90) V 50 mg bid –0.8 V 100 mg qd (n=92) V 100 mg qd –0.9 Placebo + G 4 mg qd (n=144) Placebo + G 4 mg qd 0b V 50 mg qd or bid + G 4 mg qd (n=132) Placebo (n=88) V 50 mg bid (n=79) V 100 mg bid (n=89) Placebo + I >30 U/day (n=149) V 50 mg bid + I >30 U/day (n=140) Placebo (n=72) Placebo +0.28 V 10 mg bid (n=71) V 10 mg bid –0.53 V 25 mg bid (n=72) V 25 mg bid –0.67 V 50 mg bid (n=76) V 50 mg bid –0.92 Bosi et al. 2007; Dejager et al. 2007b Dejager et al. 2007a Garber et al. 2007a Pi-Sunyer et al. 2007 Fonseca et al. 2007 Kikuchi et al. 2006; Mimori et al. 2006 21