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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02524782 | A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes | PHASE1 | COMPLETED | 103 | — | — | Oct 7, 2015 | Apr 14, 2017 | Mar 13, 2019 | 11 | United States |
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
| Arm | Type | Description |
|---|---|---|
| MEDI-4166 | EXPERIMENTAL | MEDI-4166 administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| MEDI-4166 | BIOLOGICAL | MEDI-4166 administered subcutaneously |
| Placebo | BIOLOGICAL | Placebo administered subcutaneously |
Inclusion Criteria: * Type 2 Diabetes, ages 18-65 * Must provide written informed consent * BMI\>=25 and =\<42 * Venous access suitable for multiple cannulations * Vital signs within normal specified ranges * Females must be non-lactating and non-childbearing potential * Males must practice 2 effec...