Table 5.

Effects of vildagliptin on plasma insulin, glucagon, and GLP-1 levels (all level 2 evidence).

Design	Treatment and dose	Outcome			Reference
		Mean change from baseline in 4 h-postprandial plasma insulin (pmol/L)	Mean change from baseline in 30 min postprandial glucagon (ng/mL)	Mean change from baseline in 30 min postprandial GLP-1 (pmol/L)
						Double-blind, placebo-controlled, multicenter RCT, 12 weeks	Placebo (n=58)	Placebo −30.1	NR	NR	Ristic et al. 2005
							V 25 mg bid (n=51)	V 25 mg bid +3.0
							V 25 mg qd (n=54)	V 25 mg qd −48.2
V 50 mg qd (n=53)	V 50 mg qd +2.8
V 100 mg qd (n=63)	V 100 mg qd +19.7 (P=0.022 vs placebo)
	All other doses NSD vs placebo
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	NSD between groups at 12 weeks Greater increase with V than placebo at 52 weeks (P=0.015)	NR	NR	Ahrén et al. 2004a
Double-blind, placebo-controlled, multicenter RCT, 4 weeks	Placebo (n=19) V 100 mg qd (n=18)	Insulin response to meal ingestion NSD between groups	Significant reduction in V group (P=0.005) No significant change in placebo group	Significant increase in V group (P<0.001) Placebo NR	Ahrén et al. 2004b
Double-blind, placebo-controlled RCT, 4 weeks	Placebo (n=20) V 100 mg qd (n=20)	Insulin response to meal ingestion NSD between groups	Placebo +2 V 12 (P<0.01)	Placebo +0.9 V +4.7 (P<0.001)	Ahrén et al. 2003
Double-blind, placebo-controlled, single center RCT, 4 weeks	Placebo (n=11) V 100 mg bid (n=9)	NR	3.5 h mean glucagon: lower with V than placebo but NSD	Greater increase with V than placebo in 13.5 h mean GLP-1 (P<0.001)	Mari et al. 2005

bid, twice daily; NR, not reported; NSD, not statistically significantly different; qd, once daily; RCT, randomized controlled trial; V, vildagliptin.