Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02666430 | Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients | PHASE3 | COMPLETED | 127 | — | — | Dec 1, 2015 | Jul 1, 2017 | Mar 3, 2022 | 81 | United States, Canada +6 |
| Arm | Type | Description |
|---|---|---|
| Mylan's insulin glargine | EXPERIMENTAL | 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. |
| Lantus® | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Mylan's insulin glargine | DRUG | - |
| Lantus® | DRUG | - |
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 ...