Vildagliptin | place in therapy review Table 6 | Effects of vildagliptin on beta-cell function (all level 2 evidence) Design Treatment and dose Outcome Mean change from baseline in HOMA-Ba Insulin response Insulin secretion corrected for after meal divided by peak glucose increase in plasma glucose Insulin secretory response at 7 mmol/L glucose (pmol/min/m2) NR NR NR NR NR NR NR NR NR NR NR NR NR Significant increase with V vs placebo (P<0.05) Greater increase with V than placebo at 12 weeks (P=0.0007) and 52 weeks (P=0.0005) V 50 mg qd + P 15 mg qd +8.0 (P=0.046 vs placebo + P) V 100 mg qd + P 30 mg qd +5.5 Placebo + P 45 mg qd +2 V 50 mg qd + P 45 mg qd +6 (P<0.01 vs placebo)b V 50 mg bid + P 45 mg qd +7 (P<0.01 vs placebo)b NR NR NR NR NR NR NR NR NR NR Greater with V than placebo at 12, 24, and 52 weeks (P<0.05) NR NR NR NR NR NR NR NR NR NR NR NR NR NR V 50 mg qd +5 vs placebo (P<0.001) NR NR Mari et al. 2005 Greater increase with V than placebo (P<0.005) Reference Rosenstock et al. 2007a Garber et al. 2007b Scherbaum et al. 2007 Ristic et al. 2005 Pratley & Galbreath 2004 Ahrén et al. 2004a, 2005b Double-blind, placebo-controlled RCT, 24 weeks Double-blind, placebo-controlled RCT, 24 weeks Placebo-controlled RCT, 52 weeks Double-blind, placebo-controlled, multicenter RCT, 12 weeks Double-blind, placebo-controlled RCT, 12 weeks Double-blind, placebo-controlled, multicenter RCT, 12 weeks Optional extension for further 40 weeks Double-blind, placebo-controlled, single center RCT, 4 weeks 24 Placebo + P 30 mg qd (n=157) Placebo + V 100 mg qd (n=150) V 50 mg qd + P 15 mg qd (n=139) V 100 mg qd + P 30 mg qd (n=146) Placebo + P 45 mg qd (n=138) V 50 mg qd + P 45 mg qd (n=124) V 50 mg bid + P 45 mg qd (n=136) Placebo (n=150) V 50 mg qd (n=156) Placebo (n=58) V 25 mg bid (n=51) V 25 mg qd (n=54) V 50 mg qd (n=53) V 100 mg qd (n=63) Placebo (n=28) V 25 mg bid (n=72) Placebo (n=51, of whom 29 completed extension) V 50 mg qd (n=56, of whom 42 completed extension) All patients were also taking stable doses of metformin 1.5–3 g/day Placebo (n=11) V 100 mg bid (n=9) NR NR NR NR NR NR NR NR NR NR NR Placebo –4.3 V 25 mg bid +16.9 V 25 mg qd +2.9 V 50 mg qd +6.4 V 100 mg qd +22.5 (P=0.007 vs placebo) All other doses NSD vs placebo aDefined as: HOMA-B (homeostasis model of beta-cell function) = [20 x fasting insulin (mU/L)]/(fasting glucose [mmol/L] –3.5). bData presented graphically. bid, twice daily; NR, not reported; P, pioglitazone; qd, once daily; RCT, randomized controlled trial; V, vildagliptin. © 2008 Core Medical Publishing Limited