通用名称

exenatide

儿科标签批准日期

2021/7/22 0:00:00

特定指示/秒

Type 2 diabetes mellitus in pediatric patients 10 years and older

标签更改摘要

- Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older. - Use for this indication is supported by a 24-week placebo-controlled trial with 28-week open-label uncontrolled extension in 82 pediatric patients aged 10 to less than 18 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. - Safety and effectiveness have not been established in pediatric patients less than 10 years of age. - Information on dosing, pk parameters, and clinical studies. - Postmarketing study.

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接

书号

1.0

研究年龄

11 YEARS - 17 YEARS

学习类型

Efficacy,Safety

研究设计

Multicenter,Randomized,Placebo,Double-Blind,Parallel Group,Phase 3

登记的患者

159

患者分析

82

中心的数量

36

国家数量

7

西班牙裔拉美裔/拉丁裔总计

33

非西班牙裔/非拉丁裔总人数

42

总数#种族不明

7

亚裔学生总数

3

黑人总数

25

白人总数

35

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

5

其他种族总计

14

未知种族总数

0

国家

United States,Bulgaria,Hungary,Israel,Kuwait,Mexico,Ukraine