Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

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

Detailed Description
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Mylan's insulin glargine
* Drug: Lantus®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mylan's insulin glargine<br>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. | Drug: Mylan's insulin glargine<br> <br> |
| Active Comparator: Lantus®<br>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. | Drug: Lantus®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c (HbA1c) From Baseline |  | Baseline to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose |  | Baseline to 36 weeks | 
| Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline |  | Baseline to 36 weeks | 
| Change From Baseline Total Daily Insulin Dose |  | 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 in Total Insulin Antibodies - Mylan Insulin Glargine Assay |  | Baseline to 36 weeks | 
| Change From Baseline in Total Insulin Antibodies - Lantus Assay |  | Baseline to 36 weeks | 
| Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay |  | Baseline to 36 weeks | 
| Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay |  | Baseline to 36 weeks |