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临床试验/CTRI/2023/10/059275
CTRI/2023/10/059275尚未招募4 期

Comparative efficacy of once daily versus twice daily insulin glargine in children with type 1 diabetes

surbhi bharti1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年5月11日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
mean difference in HbA1c levels

研究概览

简要总结

In some patient with type 1 diabetes the duration of action of glargine is 20 hrs resulting in hyperglycemia towars the end of 24 hrs hence twice daily dosing will improve glycemic control. Patients 8 to 18 years will be recruited and divided into 2 groups- glargine od versus bd to study mean difference in HbA1c levels

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
8.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • •HbA1c >7.5 on insulin for atleast 1 year.

排除标准

  • •past history of recurrent severe hypoglycemia.

结局指标

主要结局

mean difference in HbA1c levels

时间窗: 3 months

次要结局

  • hypoglycemic episodes(3 months)

研究者

发起方
surbhi bharti
申办方类型
Other [self]

研究点 (1)

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