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

书号

3.0 2.0 1.0

研究年龄

10 YEARS - 17 YEARS 10 YEARS - 17 YEARS 10 YEARS - 17 YEARS

学习类型

Efficacy,Safety Efficacy,Safety Efficacy,Safety

研究设计

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

登记的患者

98 124 200

患者分析

96 124 190

中心的数量

139 100 213

国家数量

31 25 42

西班牙裔拉美裔/拉丁裔总计

31 46 71

非西班牙裔/非拉丁裔总人数

57 71 110

总数#种族不明

8 7 9

亚裔学生总数

21 43 29

黑人总数

6 4 10

白人总数

49 47 98

夏威夷或太平洋岛民总数

0 2 0

美洲印第安人/阿拉斯加本地人总数

12 1 15

其他种族总计

7 27 38

未知种族总数

1 0 0

国家

United States,Argentina,Australia,Brazil,Bulgaria,Canada,Chile,Colombia,Costa Rica,Czech Republic,Denmark,Georgia,Greece,Guatemala,Honduras,Hungary,Israel,Italy,Mauritius,Mexico,Moldova, Republic of,New Zealand,Panama,Philippines,Russian Federation,Saudi Arabia,Serbia,South Africa,Sri Lanka,Taiwan,Ukraine United States,Argentina,Bulgaria,Canada,Chile,Colombia,Costa Rica,Dominican Republic,Ecuador,Germany,Guatemala,Israel,Italy,Latvia,Lithuania,Malaysia,Mexico,New Zealand,Romania,Russian Federation,Saudi Arabia,Sri Lanka,Thailand,United Arab Emirates,United Kingdom United States,Argentina,Australia,Austria,Brazil,Bulgaria,Canada,Chile,Colombia,Costa Rica,Denmark,Dominican Republic,Ecuador,France,Georgia,Germany,Greece,Guatemala,Honduras,Hungary,Israel,Italy,Latvia,Lithuania,Malaysia,Mauritius,Mexico,Moldova, Republic of,New Zealand,Panama,Philippines,Poland,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,South Africa,Spain,Sweden,Thailand,United Arab Emirates