. 2013 Dec 13;8:25–38. doi: 10.2147/DDDT.S45108

Table 3.

GetGoal Phase III clinical trial program: efficacy studies of lixisenatide either as monotherapy or combination therapy with various antidiabetic agents

Study	Study type	Intervention	HbA_1c (%)	FPG (mmol/L)	PPG (mmol/L)
GetGoal-Mono71 (n=361)	Efficacy in monotherapy	Lixisenatide^1-step	−0.7^***	−1.1^***	−3.7^***
GetGoal-Mono71 (n=361)	Efficacy in monotherapy	Lixisenatide^2-step	−0.5^***	−0.9^**	−3.1^***
GetGoal-F132 (n=482)	Efficacy combined with metformin (1-step versus 2-step dose increase)	Lixisenatide^1-step	−0.5^**	−0.53^**	N/A
GetGoal-F132 (n=482)		Lixisenatide^2-step	−0.4^***	−0.56^***	N/A
GetGoal-M72 (n=680)	Efficacy combined with metformin (morning versus evening dose)	Morning lixisenatide^2-step	−0.9^***	−1.19^**	−4.5^*
GetGoal-M72 (n=680)		Evening lixisenatide^2-step	−0.8^***	−0.81^**	NS
GetGoal-S47 (n=855)	Efficacy combined with a sulfonylurea ± metformin	Lixisenatide^2-step	−0.9^***	−0.99^***	−6.19^***
GetGoal-P48 (n=484)	Efficacy combined with pioglitazone ± metformin	Lixisenatide^2-step	−0.9^***	−1.16^***	N/A
GetGoal-L Asia52 (n=311)	Efficacy with basal insulin ± sulfonylurea	Lixisenatide^2-step	−0.8^***	−0.4^**	−7.96^***
GetGoal-L51 (n=496)	Efficacy with basal insulin ± metformin	Lixisenatide^2-step	−0.7^**	NS	−5.54^***
GetGoal-Duo 150 (n=898)	Efficacy in combination with optimally titrated basal insulin ± OAD	Lixisenatide^2-step	−0.7^***	+0.34 (NS)	−3.09^***
GetGoal-X49 (n=634)	Head-to-head versus exenatide ± metformin (noninferiority)	Lixisenatide^2-step	−0.8	−1.22 (NS)	N/A

Notes: All values are mean differences from baseline, significance level as compared with placebo. 1-Step, 1-Step dose increase of 10→20 μg; 2-Step, 2-Step dose increase of 10→15→20 μg.

P<0.05

^**

P<0.005

^***

P<0.0005. Noninferiority achieved at predefined margin of 0.4%.

Abbreviations: HbA_1c, hemoglobin A_1c; OAD, oral antidiabetic drug; FPG, fasting plasma glucose; PPG, postprandial glucose; NS, nonsignificant; NI, noninferior; N/A, not available.