EUCTR2015-004353-40-LV进行中（未招募）1 期
AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUPCLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLAN’SINSULIN GLARGINE WITH LANTUS® IN TYPE 1 DIABETES MELLITUSPATIENTS: AN EXTENSION STUDY
Mylan GmbH0 个研究点目标入组 110 人开始时间: 2016年2月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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.
- •2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
- •3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point SMBG, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the
- •extension study.
- •4. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. 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.
- •2. 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
- •3. Patients scheduled to receive another investigational drug during the extension study period
- •4. Any major elective surgery requiring hospitalization planned during the extension study period.
- •5. 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).
研究者
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