Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Mylan's insulin glargine; Lantus®
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this extension study is to assess the safety and efficacy of Mylan's insulin
      glargine and Lantus® in T1DM patients.
    

Eligibility criteria:

        Inclusion Criteria:

          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 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.

          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.

        Exclusion Criteria:

          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).