A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 478
- 试验地点
- 151
- 主要终点
- Treatment Emergent Antibody Response (TEAR)
研究概览
简要总结
The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.
详细描述
This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.
After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 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
MYL-1601D Product (100 U/mL)
干预措施: MYL-1601D Product (Drug)
FlexPen NovoLog® (100 U/mL)
干预措施: FlexPen NovoLog® (Drug)
结局指标
主要结局
Treatment Emergent Antibody Response (TEAR)
时间窗: Baseline to week 24
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
次要结局
- Change in Prandial Insulin Dose From Baseline(Baseline to week 24)
- Change in HbA1c From Baseline(Baseline to week 24)
- Change in Fasting Plasma Glucose From Baseline(Baseline to week 24)
- Change in Total Daily Insulin Dose From Baseline(Baseline to week 24)
- Change in Basal Insulin Dose From Baseline(Baseline to week 24)
- Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline(Baseline to week 24)