NCT02227862已完成3 期
An Open-Label, Randomized, Multi-Center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- Change in HbA1c From Baseline to 24 Weeks
研究概览
简要总结
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.
详细描述
This trial is a multicenter, open-label, randomized, parallel-group trial in patients with Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
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
- •Patients with an established diagnosis of T1DM per ADA 2014 criteria
- •Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
- •Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.
- •Hemoglobin ≥9.0 g/dL at screening.
排除标准
- •History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
- •History of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
- •History of use of a regular immunomodulator therapy in the 1 year prior to screening.
- •History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I), as judged by the investigator.
- •History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
- •Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
- •History of drug or alcohol dependence or abuse during the 1 year prior to screening.
研究组 & 干预措施
Mylan's Insulin Glargine
Experimental
Receive Mylan's Insulin Glargine plus insulin lispro.
干预措施: Mylan's insulin glargine (Drug)
Lantus®
Active Comparator
Receive Lantus® plus insulin lispro
干预措施: Lantus® (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to 24 Weeks
时间窗: 24 weeks
次要结局
- Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time(24 and 52 weeks)
- Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time(24 and 52 weeks)
- Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time(24 and 52 weeks)
- Change From Baseline in FPG Over Time(24 and 52 weeks)
- Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time(24 and 52 weeks)
- Occurrence of Local and Systematic Reactions(52 weeks)
- Summary of Actual and Change From Baseline in HbA1c(24 and 52 weeks)
- Hypoglycemia Occurrence(52 weeks)
- Change From Baseline in 8-point SMBG Profile Over Time(24 and 52 weeks)
- Rate of Hypoglycemic Events Per 30 Days Over Time(24 and 52 weeks)
- Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time(24 and 52 weeks)
- Proportion of Patients With HbA1c < 7%(24 and 52 weeks)
研究者
研究点 (2)
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