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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03760068 | Mylan Insulin Aspart Study | PHASE3 | COMPLETED | 478 | — | — | Nov 7, 2018 | Jan 17, 2020 | Feb 25, 2022 | 158 | United States |
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
| Arm | Type | Description |
|---|---|---|
| MYL-1601D Product (100 U/mL) | ACTIVE_COMPARATOR | - |
| FlexPen NovoLog® (100 U/mL) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MYL-1601D Product | DRUG | (100 U/mL) |
| FlexPen NovoLog® | DRUG | (100 U/mL) |
Inclusion criteria 1. Written and signed informed consent. 2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening. 3. Subject is able and willing to comply with the requirements of the study protocol. Exclusion Criteria 1. History or presence of a medical condi...