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

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT02666430

Run by

Mylan Inc.

People needed

127

Starts

2015-12-01

Expected to finish

2017-07-01

Last updated by the study team

2022-03-03

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Mylan Investigator Site — Greenbrae, California, United States
• Mylan Investigator Site — La Jolla, California, United States
• Mylan Investigator Site — Northridge, California, United States
• Mylan Investigator Site — Tustin, California, United States
• Mylan Investigator Site — Fort Lauderdale, Florida, United States
• Mylan Investigator Site — New Port Richey, Florida, United States
• Mylan Investigator Site — Palm Harbor, Florida, United States
• Mylan Investigator Site — West Palm Beach, Florida, United States
• Mylan Investigator Site — Atlanta, Georgia, United States
• Mylan Investigator Site — Columbus, Georgia, United States
• Mylan Investigator Site — Idaho Falls, Idaho, United States
• Mylan Investigator Site — Crystal Lake, Illinois, United States
• Mylan Investigator Site — Springfield, Illinois, United States
• Mylan Investigator Site — Des Moines, Iowa, United States
• Mylan Investigator Site — Overland Park, Kansas, United States
• Mylan Investigator Site — Lexington, Kentucky, United States
• Mylan Investigator Site — Billings, Montana, United States
• Mylan Investigator Site — Omaha, Nebraska, United States
• Mylan Investigator Site — Albany, New York, United States
• Mylan Investigator Site — Staten Island, New York, United States
• Mylan Investigator Site — Syracuse, New York, United States
• Mylan Investigator Site — Asheville, North Carolina, United States
• Mylan Investigator Site — Burlington, North Carolina, United States
• Mylan Investigator Site — Greenville, North Carolina, United States
• Mylan Investigator Site — Fresno, California, United States

Full record on ClinicalTrials.gov

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