6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 463
- 试验地点
- 107
- 主要终点
- Change From Baseline in HbA1c to Month 6
研究概览
简要总结
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus.
.
Secondary Objectives:
To compare HOE901-U300 and Lantus in terms of:
- Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).
- To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
详细描述
The study duration per participant was approximately 58 weeks that consisted of a 2 week screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month comparative safety extension period, and a 4-week post treatment follow up period.
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
HOE901-U300
HOE901-U300 (Insulin glargine 300 Units/milliliter [U/mL]) Subcutaneous(SC) injection once daily for 12 months.
干预措施: Insulin glargine,300 U/mL (Drug)
HOE901-U300
HOE901-U300 (Insulin glargine 300 Units/milliliter [U/mL]) Subcutaneous(SC) injection once daily for 12 months.
干预措施: Background therapy (Drug)
Lantus
Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.
干预措施: Insulin glargine (100 units /mL) (Drug)
Lantus
Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.
干预措施: Background therapy (Drug)
结局指标
主要结局
Change From Baseline in HbA1c to Month 6
时间窗: Baseline to Month 6
Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.
次要结局
- Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period(upto Month 6)
- Percentage of Participants With HbA1c Values of <7.5% at Month 6(Month 6)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6(Baseline to Month 6)
- Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6(Month 6)
- Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6(Baseline to Month 6)
- Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6(Baseline, Month 6)
- Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point(Baseline to Month 6)
- Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12(Month 12)
- Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period(upto Month 6)
- Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12(Month 12)