A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)
研究概览
简要总结
Primary Objective:
Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment
Secondary Objectives:
Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
insulin glulisine and insulin glargine
insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12)
干预措施: INSULIN GLULISINE (Drug)
insulin glulisine and insulin glargine
insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12)
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)
时间窗: at 6 and 12 months of treatment
次要结局
- Change in HbA1c plasma level(at 6 and 12 months of treatment)
- Monthly rate of hypoglycaemia(from baseline to 12 months of treatment (study cut off))
- Change in daily dose of glargine and glulisine(at 6 and 12 months of treatment)