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: An Extension Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline
研究概览
简要总结
The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.
详细描述
This multi-center, open-label, randomized clinical extension study in patients with T1DM will assess safety and efficacy of Mylan's insulin glargine and Lantus®.
Patients with an established diagnosis of T1DM per American Diabetes Association 2014 criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study, and who have completed the 52-week treatment period on Lantus® will be eligible to be screened for the MYL-1501D-3003 study.
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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.
- •Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
- •The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study.
- •Female patients complying with the following:
- •Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study.
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.
- •Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study.
- •All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.
- •If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study.
排除标准
- •History or presence of a medical condition or disease that in the Investigator's opinion would place the patient at an unacceptable risk from trial participation.
- •History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient history) in to the MYL-1501D-3003 extension study
- •Patients scheduled to receive another investigational drug during the extension study period
- •Any major elective surgery requiring hospitalization planned during the extension study period.
- •Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylan's insulin glargine in IU/kg/day).
研究组 & 干预措施
Mylan's insulin glargine
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
干预措施: Mylan's insulin glargine (Drug)
Lantus®
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
干预措施: Lantus® (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline
时间窗: Baseline to 36 weeks
次要结局
- Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay(Baseline to 36 weeks)
- Local and Systemic Allergic Reactions(Baseline to 40 weeks)
- Hypoglycemic Rate(Baseline to 36 weeks)
- Hypoglycemic Incidence(Baseline to 36 weeks)
- Change From Baseline Total Daily Insulin Dose(Baseline to 36 weeks)
- Change From Baseline in Total Insulin Antibodies - Lantus Assay(Baseline to 36 weeks)
- Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline(Baseline to 36 weeks)
- Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay(Baseline to 36 weeks)
- Change From Baseline in Fasting Plasma Glucose(Baseline to 36 weeks)
- Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay(Baseline to 36 weeks)