To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks
This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Change in HbA1c From Baseline to 24 Weeks
Time frame: 24 weeks
Rate of Hypoglycemic Events Per 30 Days
The change from baseline at 12 and 24 weeks is reported
Time frame: Baseline and up to 24 weeks
Hypoglycemia Occurrence
Overall hypoglycemic incidence during treatment period
Time frame: 24 weeks
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Comparison of change from Baseline in Immunogenicity
Time frame: Week 12 and week 24
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Comparison of change from Baseline in Immunogenicity
Time frame: week 12 and week 24
Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Comparison of change from Baseline in Immunogenicity
Time frame: week 12 and week 24
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Comparison of change from Baseline in Immunogenicity
Time frame: Week 12 and week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mylan Investigational Site
Chandler, Arizona, United States
Mylan Investigational Site
Bell Gardens, California, United States
Mylan Investigational Site
Fresno, California, United States
Mylan Investigational Site
Greenbrae, California, United States
Mylan Investigational Site
Long Beach, California, United States
Mylan Investigational Site
Los Angeles, California, United States
Mylan Investigational Site
Los Gatos, California, United States
Mylan Investigational Site
Mission Hills, California, United States
Mylan Investigational Site
National City, California, United States
Mylan Investigational Site
Northridge, California, United States
...and 110 more locations