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Mylan's insulin glargine · 3 trials · 3 indications
| 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 ...
Mylan's insulin glargine is an investigational long-acting insulin being developed for the treatment of Type 1 Diabetes, Type 1 Diabetes Mellitus, and Type 2 Diabetes. It is intended as a potential biosimilar to Lantus, and clinical trials have evaluated its efficacy and safety in adult patients with these conditions.
Mylan's insulin glargine is being developed by Viatris Inc., which trades under the ticker VTRS. The drug is a small molecule therapeutic in the metabolic area, and it has completed Phase 3 clinical trials for diabetes indications.
Mylan's insulin glargine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials have been completed, and the drug is no longer in active clinical testing according to the trial data.
Mylan's insulin glargine has been studied in three completed Phase 3 trials. NCT02227862 (INSTRIDE 1) compared it to Lantus in 558 patients with Type 1 Diabetes. NCT02227875 (INSTRIDE 2) compared it to Lantus in 560 patients with Type 2 Diabetes. NCT02666430 was an extension study in 127 patients with Type 1 Diabetes Mellitus.
Mylan's insulin glargine is a long-acting insulin analog that works by replacing the insulin that the body normally produces. It helps regulate glucose metabolism by promoting the uptake of glucose into cells and inhibiting the production of glucose in the liver, thereby controlling blood sugar levels in patients with diabetes.