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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01144975 | Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 76 | — | — | May 1, 2010 | Oct 1, 2011 | May 16, 2012 | 1 | Mexico |
| NCT01066715 | Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy | PHASE2 | COMPLETED | 421 | — | — | Jan 1, 2010 | Jul 1, 2011 | Oct 4, 2011 | 67 | United States |
| Arm | Type | Description |
|---|---|---|
| XOMA 052 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| XOMA 052 | DRUG | Sterile solution, dose level varies by dose group and study drug administration day, SC injections administered by study personnel at time points specified in the protocol (the subject will receive a total of 8 injections) |
| Placebo | DRUG | Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections) |
Inclusion Criteria: * Diagnosed with T2D (disease duration \>= 6 months) * HbA1c measurements \>= 7.0% and \<= 10.0% * On a stable regimen of metformin monotherapy * Age \>= 18 and \<= 75 * Stable diet and exercise regimen * BMI \<= 40 kg/m2 Exclusion Criteria: * Significant signs and symptoms of...