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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02349802 | Autoinjector Device Assessment Study | PHASE1 | COMPLETED | 3,052 | — | — | Feb 1, 2013 | Dec 1, 2013 | Feb 2, 2015 | 2 | United States |
The primary outcome measure is the number of device-related injection failures of the single-use, pre-filled auto-injector.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 2 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 3 | EXPERIMENTAL | exenatide suspension - 4.5 mg /1.1 mL |
| Arm 4 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.1 mL |
| Arm 5 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.5 mL |
| Name | Type | Description |
|---|---|---|
| Auto-injector with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
| Syringe with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
Inclusion Criteria: * Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent. * Has no significant health issues that would preclude study participation, as determined by medical history and physical examination * Has body mass index of 22 kg/m2 to 45 kg/m2, inclu...