胰岛素及其临床应用.ppt

Hypoglycemia Rate With Insulin Lispro and Regular Human Insulin (Type 2 Diabetes) Baseline Regular Lispro P-Value Overall 3.13±0.20 2.79 ±0.17 2.67 ±0.017 0.31 Midnight － 0.73 ±0.07 0.47 ±0.05 < 0.001 to 6 AM Anderson JH, et al, Archives of Int, Med. 1997; 157: 1249-1255. 第三十页，共七十五页，2022年，8月28日 Hypoglycemia Rate by Time of Day With Humalog ? and Humulin ? R in Type 1 Patients: Unblinded Crossover Study 2 4 6 8 10 Number of Episodes of Hypoglycemia per 30 Days p < 0.001 p = 0.742 p < 0.001 Midnight - 6 AM 6 AM - Noon Noon - 6 PM 6 PM - Midnight Humalog HumulinR p < 0.001 Anderson JH, et al, Diabetes. 1997; 46: 265 第三十一页，共七十五页，2022年，8月28日 Meta-Analysis of Severe Hypoglycemia in Type 1 Diabetes Number of Sevee Hypoglycemic Episodes * Regular Insulin 60 80 100 120 140 20 40 30 % reduction * p = 0.024 Insulin Lispro Burnelle, et al. Diabetes Care 1998; 21 (10); 1726-31 第三十二页，共七十五页，2022年，8月28日 Immunogenicity Antibodies measured: Insulin lispro specific Human insulin specific Cross-reactive (binds both insulin lispro and other insulins) E. coli polypeptides 第三十三页，共七十五页，2022年，8月28日 INSULIN LISPRO Humalog ? Immunogenicity No significant differences in endpoint antibody binding levels eith insulin lispro and regular human insulin therapy in patients not previously treated with inslulin No significant differences in baseline lispro and regular human insulin therapy in patheits previously exposed to insulin Type 1 patients formed higher levels of antibodies than Type 2 patients 第三十四页，共七十五页，2022年，8月28日 INSULIN LISPRO Humalog ?Adverse Events Across all studies (n=3046) there were no clinically significant between-treatment differences for deaths, discontinuations, or adverse events when comparing insulin lispro with regular human insulin 第三十五页，共七十五页，2022年，8月28日 Insulin Lispro in CSII Double-blind crossover trial Insulin lispro vs human regular insulin 30 type 1 patients Age: 26 - 51 years (