Type 1 Diabetes Mellitus MedDRA version: 19.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Mylan GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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-1501D-3003 study. - Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-1501D-3003 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-1501D-3003 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 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the equivalence of changes in HbA1C between two treatment sequence groups, when Mylan's insulin glargine and Lantus® are interchanged (Mylan's insulin glargine and Lantus® are administered in combination with mealtime insulin lispro).;Secondary Objective: To compare: - Change in basal insulin dose per unit body weight (U/Kg/day) - Immunogenicity: incidence and change from baseline in the relative levels of ADA, incidence and change from baseline the relative levels o anti-HCP antibodies. - Rate of hypoglycemic events per 30 days; and occurrence of hypoglycemia - Occurrence of local reactions, systemic reactions and other adverse events - Change in fasting plasma glucose - Change in 8-point SMBG profile - Device-related safety assessments in patients when Mylan’s insulin glargine and Lantus® are interchanged (Mylan’s insulin glargine and Lantus® are administered in combination with mealtime insulin lispro). ;Primary end point(s): The HbA1c difference of change from baseline between two periods at 12 weeks from week 36. If week 36 HbA1c is missing then last non-missing values from period 3 will be used.;Timepoint(s) of evaluation of this end point: At week 12 and week 24 and week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy measures both actual and change in values: 1) Fasting plasma glucose; 2) SMBG value: individual pre-meal, individual post-meal, individual 2-hour excursion after meal, bedtime, overall (average) pre-meal, overall post-meal, overall excursion, 4-point average (pre-meal + bedtime), and daily average; 3) Daily prandial insulin, basal insulin, and total insulin dose (U/kg) for days of 8-point profiles. Safety measures: 1) Immunogenicity analyzes 2) Hypoglycemia analyzes 3) Adverse events analyzes 4) Device safety assesment ;Timepoint(s) of evaluation of this end point: 1) Week 8, 12, 20, 24, 36 2) Week 2, 4, 8, 12, 14, 16, 20, 24, 26, 28, 32, 36 3) Week 2, 4, 8, 12, 14, 16, 20, 24, 26, 28, 32, 36 Safety measures: -at each study visit, until week 40 except immunogenicity and Device safety assesment until week 36 | — |
Countries
Canada, Czech Republic, Estonia, Germany, Hungary, Latvia, Slovakia, United States
Contacts
Public ContactDavid Gillogly, Head of Global CO
Mylan, Inc.
Outcome results
None listed