Table 4.
Effects of vildagliptin on blood glucose and glycosylated hemoglobin (HbA1c) in placebo-controlled studies (all level 2 evidence)
| Design | Treatment and dose |
Outcome |
Reference | |||
|---|---|---|---|---|---|---|
| Mean change from baseline in HbA1c (percentage points) | % patients reaching HbA1c <7.0%a | Mean change from baseline in fasting plasma glucose (mmol/L) | Mean change from baseline in 4 h-postprandial plasma glucose (mmol/L) | |||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo + M ≥1.5 g (n=130) | Placebo + M ≥1.5 g +0.2 | Placebo + M ≥1.5 g 9.4% | NR | NR | Bosi et al. 2007; Dejager et al. 2007b |
| V 50 mg qd + M ≥1.5 g (n=143) | V 50 mg qd + M ≥1.5 g −0.5 (P<0.001 vs placebo) | NR | NR | NR | ||
| V 100 mg qd + M ≥1.5 g (n=143) | V 100 mg qd + M ≥1.5 g −0.9 (P<0.001 vs placebo) | V 100 mg qd + M ≥1.5 g 35.5% (P<0.001 vs placebo) | NR | NR | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo (n=94) | Placebo −0.3 | NR | Placebo −0.1 | NR | Dejager et al. 2007a |
| V 50 mg qd (n=104) | V 50 mg qd −0.8 | NR | V 50 mg qd −1.0 | NR | ||
| V 50 mg bid (n=90) | V 50 mg bid −0.8 | NR | V 50 mg bid −0.8 | NR | ||
| V 100 mg qd (n=92) | V 100 mg qd −0.9 (all P<0.01 vs placebo) | NR | V 100 mg qd −0.8 | NR | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo + G 4 mg qd (n=144) | Placebo + G 4 mg qd 0b | NR | Greater decrease with V than with placebo at (P=0.118)c | NR | Garber et al. 2007a |
| V 50 mg qd or bid + G 4 mg qd (n=132) | V 50 mg qd or bid + G 4 mg qd −0.7b (P<0.001 vs placebo) | NR | NR | NR | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo (n=88) | Placebo 0 | Placebo 13.6% | Placebo +0.1 | NR | Pi-Sunyer et al. 2007 |
| V 50 mg bid (n=84) | V 50 mg qd −0.5 | V 50 mg qd 25%c | V 50 mg qd −0.5 | NR | ||
| V 50 mg bid (n=79) | V 50 mg bid −0.7 (P<0.001 vs placebo) | V 50 mg bid 30.4% (P<0.01 vs placebo) | V 50 mg bid −1.2 (P<0.001 vs placebo) | NR | ||
| V 100 mg bid (n=89) | V 100 mg qd −0.8 (P<0.001 vs placebo) | V 100 mg qd 39.1% (P<0.001 vs placebo) | V 100 mg qd −1.1 (P<0.001 vs placebo) | NR | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo + I >30 U/day (n=149) | Placebo + I >30 U/day −0.2 | NR | Placebo + I >30 U/day −0.8 | NR | Fonseca et al. 2007 |
| V 50 mg bid + I >30 U/day (n=140) | V 50 mg bid + I >30 U/day −0.5 (P=0.01 vs placebo) | NR | V 50 mg bid + I >30 U/day −0.2 | NR | ||
| Double-blind, placebo-controlled RCT, 12 weeks | Placebo (n=72) | Placebo +0.28 | NR | Placebo +0.13 | Placebo +0.2d | Kikuchi et al. 2006; Mimori et al. 2006 |
| V 10 mg bid (n=71) | V 10 mg bid −0.53 | NR | V 10 mg bid −0.62 | V 10 mg bid −3.5d | ||
| V 25 mg bid (n=72) | V 25 mg bid −0.67 | NR | V 25 mg bid −0.78 | V 25 mg bid −3.2d | ||
| V 50 mg bid (n=76) | V 50 mg bid −0.92 (all P<0.001 vs placebo) | NR | V 50 mg bid −1.37 (all P<0.001 vs placebo) | V 50 mg bid −3.4d (all P<0.001 vs placebo) | ||
| Double-blind, placebo-controlled RCT, 12 weeks | Placebo (n=28) | Placebo −0.6 | Placebo NR | Placebo +0.23 | Placebo +0.2 | Pratley et al. 2006; Pratley & Galbreath 2004 |
| V 25 mg bid (n=70) | V −0.6 (P=0.0012) | V 47% | V −0.9 (P=0.0043) | V −1.7 (P<0.0001) | ||
| Double-blind, placebo-controlled, multicenter RCT, 12 weeks | Placebo (n=58) | NR | Placebo 23% | Placebo −0.41 | Placebo −0.61 | Ristic et al. 2005 |
| V 25 mg bid (n=51) | NR | V 25 mg bid 44% | V 25 mg bid −0.44 | V 25 mg bid −1.03 | ||
| V 25 mg qd (n=54) | NR | V 25 mg qd 28% | V 25 mg qd −0.30 | V 25 mg qd −1.50 | ||
| V 50 mg qd (n=53) | V 50 mg qd −0.56 (P=0.003 vs placebo) | V 50 mg qd 40% | V 50 mg qd −0.97 | V 50 mg qd −2.00 (P=0.012 vs placebo) | ||
| V 100 mg qd (n=63) | V 100 mg qd −0.53 (P=0.004 vs placebo) | V 100 mg qd 46% | V 100 mg qd −0.95 | V 100 mg qd −1.50 | ||
| Other doses NSD vs placebo | P values NR | All doses NSD vs placebo | All other doses NSD vs placebo | |||
| Double-blind, placebo-controlled, multicenter RCT, 12 weeks | Placebo (n=51, of whom 29 completed extension) | At 12 weeks: V −0.6 Placebo 0.1 (P<0.0001) | Placebo 10.7% V 41.7% P value NR | Greater decrease with V than with placebo at 12 weeks (P=0.0057) | Greater decrease with V than with placebo at 12 weeks (P<0.0001) | Ahrén et al. 2004a |
| Optional extension for further 40 weeks | V 50 mg qd (n=56, of whom 42 completed extension) All patients were also taking stable doses of M 1.5–3 g/day |
In extension study: V +0.0128 per month Placebo +0.0656 per month (P=0.0243) |
Greater decrease with V than with placebo at 52 weeks (P=0.031) | Greater decrease with V than with placebo at 52 weeks (P=0.0001) | ||
| Double-blind, placebo-controlled, multicenter RCT, 4 weeks | Placebo (n=19) | Placebo −0.15 | NR | Placebo −0.4 | Placebo −0.4 | Ahrén et al. 2004b |
| V 100 mg qd (n=18) | V −0.53 (P<0.001) | NR | V −1.1 (P=0.037) | V −1.9 (P<0.001) | ||
| Double-blind, placebo-controlled RCT, 4 weeks | Placebo (n=20) | NR | NR | Placebo −0.3 | NR | Ahrén et al. 2003 |
| V 100 mg qd (n=20) | NR | NR | V −1.0 (P<0.05) | NR | ||
| Double-blind, placebo-controlled, single center RCT, 4 weeks | Placebo (n=11) | NR | NR | Greater decrease with V than placebo (P<0.05) | NR | Mari et al. 2005 |
| V 100 mg bid (n=9) | NR | NR | NR | NR | ||
a
Of patients with HbA1c ≥7.0% at baseline.
b
Placebo subtracted value.
c
Results presented graphically, not stated.
d
2 h-postprandial plasma glucose.
bid, twice daily; G, glimepiride; I, insulin; M, metformin; NR, not reported; NSD, not statistically significantly different; qd, once daily; RCT, randomized controlled trial; V, vildagliptin.