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
Mean HbA1c (%) Baseline LS mean change from baseline 8.39 -0.74 8.38 -0.38 8.53 -0.77 8.53 0.11 Patients (%) achieving HbA1c < 7.0% 28.3 12.0 35.6 5.2 Mean change in basal insulin dose (U) Baseline LS mean change from baseline 53.62 -5.62 57.65 -1.93 24.87 -1.39 24.11 -0.11 Mean body weight (kg) Baseline LS mean change from baseline 87.39 -1.80 89.11 -0.52 65.99 -0.38 65.60 0.06 *Performed in Asian population The mean decrease in fasting plasma glucose obtained with lixisenatide treatment ranged from 0.42 mmol/L to 1.19 mmol/L at the end of the main 24-week treatment period in studies. controlled placebo-
The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period. The most common adverse events which led to treatment discontinuation in the Lyxumia group were nausea (3.1%) and vomiting (1.2%). Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly. Lyxumia is administered once daily within the hour prior to the first meal of the day or the evening meal. The starting dose is 10 mcg (µg) Lyxumia once daily for 14 days. Then, the Lyxumia dose should be increased to 20 mcg (µg) once daily, which is the maintenance dose. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is to a combination of a basal insulin and a sulphonylurea, a reduction in the dose of the basal insulin or the sulphonylurea may be considered according to individual response to reduce the risk of hypoglycaemia (see PRECAUTIONS). When used in combination with basal insulin and a sulphonylurea, blood glucose monitoring may become necessary to adjust the doses of the basal insulin or the sulphonylurea. In the absence of compatibility studies, Lyxumia must not be mixed with other medicinal products. Inspect Lyxumia before each use. Lyxumia must only be used if the solution is clear, colourless, with no particles visible. Lyxumia should not be used if it has been frozen. Lyxumia can be used with 29 to 32 gauge disposable pen needles. Pen needles are not included. The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached. This helps prevent contamination and potential needle blockage.
Solution for injection in purple pre-filled injector pen containing 3 mL solution delivering 14 doses of 20 μg. Each dose (0.2 mL) contains 20 μg of lixisenatide (0.1 mg/mL). Supplied in packs of 1 (14 days supply), 2 (28 days supply) and 6 (84 days supply) injector pens. TREATMENT (1 + 1 Solution for injection composite pack containing 1 pre-filled 10 μg pen (14 days supply), and 1 purple pre-filled 20 μg pen (14 days supply; 28 days total supply). Each dose (0.2 mL) from the 10 μg pen contains 10 μg of lixisenatide (0.05 mg/mL). Each dose (0.2 mL) from the 20 μg pen contains 20 μg of lixisenatide (0.1 mg/mL). sanofi-aventis pty ltd Park NSW 2113 Schedule 4 (Prescription Only Medicine) 10 2013