Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Mylan Investigator Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Mylan's insulin glargine
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.
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.