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 corrected for peak glucose | Insulin secretion after meal divided by increase in plasma glucose | Insulin secretory response at 7 mmol/L glucose (pmol/min/m2) | Reference | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo + P 30 mg qd (n=157) | NR | NR | NR | NR | Rosenstock et al. 2007a |
| Placebo + V 100 mg qd (n=150) | NR | NR | NR | NR | ||
| V 50 mg qd + P 15 mg qd (n=139) | NR | NR | V 50 mg qd + P 15 mg qd +8.0 (P=0.046 vs placebo + P) | NR | ||
| V 100 mg qd + P 30 mg qd (n=146) | NR | NR | V 100 mg qd + P 30 mg qd +5.5 | NR | ||
| Double-blind, placebo-controlled RCT, 24 weeks | Placebo + P 45 mg qd (n=138) | NR | NR | Placebo + P 45 mg qd +2 | NR | Garber et al. 2007b |
| V 50 mg qd + P 45 mg qd (n=124) | V 50 mg qd + P 45 mg qd +6 (P<0.01 vs placebo)b | |||||
| V 50 mg bid + P 45 mg qd (n=136) | NR | NR | V 50 mg bid + P 45 mg qd +7 (P<0.01 vs placebo)b | NR | ||
| Placebo-controlled RCT, 52 weeks | Placebo (n=150) | NR | NR | NR | NR | Scherbaum et al. 2007 |
| V 50 mg qd (n=156) | NR | NR | NR | V 50 mg qd +5 vs placebo (P<0.001) | ||
| Double-blind, placebo-controlled, multicenter RCT, 12 weeks | Placebo (n=58) | Placebo −4.3 | NR | NR | NR | Ristic et al. 2005 |
| V 25 mg bid (n=51) | V 25 mg bid +16.9 | NR | NR | NR | ||
| V 25 mg qd (n=54) | V 25 mg qd +2.9 | NR | NR | NR | ||
| V 50 mg qd (n=53) | V 50 mg qd +6.4 | NR | NR | NR | ||
| V 100 mg qd (n=63) | V 100 mg qd +22.5 (P=0.007 vs placebo) | NR | NR | NR | ||
| All other doses NSD vs placebo | ||||||
| Double-blind, placebo-controlled RCT, 12 weeks | Placebo (n=28) | NR | Significant increase with V vs placebo (P<0.05) | NR | NR | Pratley & Galbreath 2004 |
| V 25 mg bid (n=72) | ||||||
| Double-blind, placebo-controlled, multicenter RCT, 12 weeks Optional extension for further 40 weeks |
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 |
NR | Greater increase with V than placebo at 12 weeks (P=0.0007) and 52 weeks (P=0.0005) | Greater with V than placebo at 12, 24, and 52 weeks (P<0.05) | NR | Ahrén et al. 2004a, 2005b |
| Double-blind, placebo-controlled, single center RCT, 4 weeks | Placebo (n=11) | NR | NR | NR | Greater increase with V than placebo (P<0.005) | Mari et al. 2005 |
| V 100 mg bid (n=9) | ||||||
a
Defined as: HOMA-B (homeostasis model of beta-cell function) = [20 x fasting insulin (mU/L)]/(fasting glucose [mmol/L] −3.5).
b
Data presented graphically.
bid, twice daily; NR, not reported; P, pioglitazone; qd, once daily; RCT, randomized controlled trial; V, vildagliptin.