Mean (%) Baseline 8.12 7.99 8.03 8.07 8.07 8.02 LS mean change from -0.83 -0.92 -0.42 -0.87 -0.75 -0.38 baseline Patients (%) 42.1 47.4 24.1 43.0 40.6 22.0 achieving HbA1c < 7.0% Mean body weight (kg) Baseline 88.08 90.30 87.86 90.14 89.01 90.40 LS mean change from -2.68 -2.63 -1.63 -2.01 -2.02 -1.64 baseline *Two dose initiation regimens of 2-week duration were evaluated in this study; they both were followed by a maintenance period with lixisenatide 20 µg once daily. The one-step initiation (10 µg for two weeks) followed by 20 µg for maintenance is the regimen recommended for use. In an active-controlled study in combination with metformin, lixisenatide once daily showed a non inferior HbA1c reduction compared to exenatide twice daily at the end of the main 24-week treatment period (respectively - 0.79 % and -0.96%, with a mean treatment difference of 0.17% [95% CI: 0.033, 0.297). Table 2 Active study in combination with metformin (24-week results) –controlled Metformin as background therapy Lixisenatide 20mcg once Exenatide 10 mcg twice daily daily (N= 315) (N= 315) Mean HbA1c (%) 7.97 7.96 Baseline LS mean change from baseline -0.79 -0.96 Patients ( %) achieving HbA1c < 7.0% 48.5 49.8% Mean body weight (kg) 94.51 96.69 Baseline LS mean change from baseline -2.96 -3.98
Mean (%) Baseline LS mean change from baseline 8.12 -0.83 7.99 -0.92 8.03 -0.42 8.07 -0.87 8.07 -0.75 8.02 -0.38 Patients (%) achieving HbA1c < 7.0% 42.1 47.4 24.1 43.0 40.6 22.0 Mean body weight (kg) Baseline LS mean change from baseline 88.08 -2.68 90.30 -2.63 87.86 -1.63 90.14 -2.01 89.01 -2.02 90.40 -1.64 *Two dose initiation regimens of 2-week duration were evaluated in this study; they both were followed by a maintenance period with lixisenatide 20 µg once daily. The one-step initiation (10 µg for two weeks) followed by 20 µg for maintenance is the regimen recommended for use. In an active-controlled study in combination with metformin, lixisenatide once daily showed a non inferior HbA1c reduction compared to exenatide twice daily at the end of the main 24-week treatment period (respectively - 0.79 % and -0.96%, with a mean treatment difference of 0.17% [95% CI: 0.033, 0.297). Table 2 Active –controlled study in combination with metformin (24-week results) Metformin as background therapy Lixisenatide 20mcg once daily (N= 315) Exenatide 10 mcg twice daily (N= 315) Mean HbA1c (%) Baseline LS mean change from baseline 7.97 -0.79 7.96 -0.96 Patients ( %) achieving HbA1c < 7.0% 48.5 49.8% Mean body weight (kg) Baseline LS mean change from baseline 94.51 -2.96 96.69 -3.98
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