Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
otelixizumab infusion plus physician determined standard of care · 1 trial · 1 indication
Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.
| Arm | Type | Description |
|---|---|---|
| otelixizumab | EXPERIMENTAL | otelixizumab |
| placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| otelixizumab infusion plus physician determined standard of care | BIOLOGICAL | infusion |
| placebo infusion plus physician determined standard of care | BIOLOGICAL | infusion |
Inclusion Criteria: * Ages 12-45 * Diagnosis of diabetes mellitus, consistent with ADA criteria * No more than 90 days between diagnosis and administration of study compounds * Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration o...