A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 162
- 试验地点
- 10
- 主要终点
- Absolute change of glycosylated hemoglobin (HbA1c)
研究概览
简要总结
Primary Objective:
6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.
Secondary Objectives:
-
To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:
-
Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
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Fasting blood glucose (FBG),
-
Nocturnal blood glucose (BG),
-
24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
-
Daily total insulin dose and basal insulin dose,
-
Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
-
To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
-
To assess anti-insulin and anti-glargine antibody development in both groups.
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To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing
详细描述
The study duration for each patient is 28 weeks +/- 7 day broken down as follows:
- Screening phase: up to 2 weeks
- Run-in phase: 1 week
- Treatment phase: 24 weeks
- Follow-up: 1 week
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 glargine
injection once daily at bedtime
干预措施: Insulin glargine (HOE901) (Drug)
NPH insulin
injection once daily at bedtime or twice daily in the morning and at bedtime
干预措施: NPH insulin (Drug)
结局指标
主要结局
Absolute change of glycosylated hemoglobin (HbA1c)
时间窗: from baseline to week 24
次要结局
- Anti-glargine and anti-human insulin antibody assessment(at screening, week 4, week 24)
- Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)(from baseline to week 24)
- Change in total insulin dose and basal insulin dose(from baseline to week 24)
- Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.(during 24-week treatment period)
- Change in nocturnal Blood Glucose (BG)(from baseline to week 24)
- Change in Fasting Blood Glucose (FBG)(from baseline to week 24)
- Percentage of patients reaching HbA1c < 7.5%(at week 24)