Results Primary endpoint 8: Primary endpoint (6 month change in HbA1c) Study N U300 Baseline 6 Change U300 Difference 95% U100 HbA1c% U300 HbA1c% U300 U100 CI U100 U100 12456 273 8.13 7.70 -0.40 0.04 T1DM 273 8.12 7.68 -0.44 (-0.098, 0.185 11628 404 8.13 7.23 -0.90 -0.03 T1DM 400 8.14 7.27 -0.87 (-0.144, 0.083) Basal insulin experienced Mealtime insulin +/- oral agents 403 8.27 7.47 -0.73 -0.03 (-0.168, 0.099) T2DM 405 8.22 7.49 -0.70 Basal insulin experienced also on oral agents 12347 432 8.49 7.08 -1.42 0.04 T2DM 430 8.58 7.05 -1.46 (-0.090, 0.174) Insulin naïve Also on oral agents Pooled 835 8.38 7.27 -1.08 0.01 12347/11629 835 8.40 7.27 -1.09 (-0.083, 0.106) Also on oral agents Comment: All results met the pre-specified non-inferiority margin of 0.4%. That is, none of the upper 95% confidence limits were above 0.4%. There is an argument that the non-inferiority margin should be 0.3%, p11 of the EMA Guideline on medicinal product for diabetes: (CPMP/EWP/1080/00 Rev. 1 2012); this margin was also met. Insulin dose Table 9: Insulin dose Study Baseline 6 month Increase U300 U300 U300 U100 U100 U100 12456 33.5U 40.5U 21% T1DM 31.5U 34.1U 8%
Results Primary endpoint 8: Primary endpoint (6 month change in HbA1c) Study N U300 U100 Baseline HbA1c% U300 U100 6 HbA1c% U300 U100 Change U300 U100 Difference 95% CI 12456 T1DM 273 273 8.13 8.12 7.70 7.68 -0.40 -0.44 0.04 (-0.098, 0.185 11628 T1DM Basal insulin experienced Mealtime insulin +/- oral agents 404 400 8.13 8.14 7.23 7.27 -0.90 -0.87 -0.03 (-0.144, 0.083) T2DM Basal insulin experienced also on oral agents 403 405 8.27 8.22 7.47 7.49 -0.73 -0.70 -0.03 (-0.168, 0.099) 12347 T2DM Insulin naïve Also on oral agents 432 430 8.49 8.58 7.08 7.05 -1.42 -1.46 0.04 (-0.090, 0.174) Pooled 12347/11629 Also on oral agents 835 835 8.38 8.40 7.27 7.27 -1.08 -1.09 0.01 (-0.083, 0.106) Comment: All results met the pre-specified non-inferiority margin of 0.4%. That is, none of the upper 95% confidence limits were above 0.4%. There is an argument that the non-inferiority margin should be 0.3%, p11 of the EMA Guideline on medicinal product for diabetes: (CPMP/EWP/1080/00 Rev. 1 2012); this margin was also met. Insulin dose Table 9: Insulin dose Study Baseline U300 U100 6 month U300 U100 Increase U300 U100 12456 T1DM 33.5U 31.5U 40.5U 34.1U 21% 8%
auspar-insulin-glargine-rbe-170106.docx