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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03376789 | Mylan Insulin Glargine Study | PHASE3 | COMPLETED | 219 | — | — | Nov 29, 2017 | Jan 10, 2019 | Mar 3, 2022 | 38 | United States |
Change in HbA1c from baseline
| Arm | Type | Description |
|---|---|---|
| MYL-1501D (Process V Product) | ACTIVE_COMPARATOR | MYL-1501D (Process V Product) |
| MYL-1501D (Process VI Product) | ACTIVE_COMPARATOR | MYL-1501D (Process VI Product) |
| Name | Type | Description |
|---|---|---|
| MYL-1501D product using manufacture process V | DRUG | MYL-1501D product using manufacture process V |
| MYL-1501D product using manufacture process VI | DRUG | MYL-1501D product using manufacture process VI |
Inclusion Criteria: 1. Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures. 2. Male and female subjects between the ages of 18 to 65 years, both ages inclusive. 3. Subjects with an established diagnosis...