通用名称

sitagliptin; sitagliptin/metformin HCl

儿科标签批准日期

2020/12/4 0:00:00

特定指示/秒

Type 2 diabetes mellitus

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients. - Three 20-week double-blind, placebo-controlled studies each with 34-week extensions were conducted to evaluate the efficacy and safety of sitagliptin in 410 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes, with or without insulin therapy - In both efficacy analyses, the effect of treatment with sitagliptin was not significantly different from placebo. - Information on adverse reactions, and clinical trials.

治疗类别

Type 2 Diabetes

立法类型

BPCA Only

产品说明书链接