Table 1:
Analysis of insulin secretion to oral glucose in the first 6 months after treatment
| Measure to be compared between arms | Medians | p-value | |
|---|---|---|---|
| Placebo | Teplizumab | ||
| First hour insulin interval secretion | |||
| Pre-treatment slope | −259.5 | −422.7 | 0.79 |
| Post-treatment slope | −476.2 | 371.0 | 0.0003 |
| Paired pre- vs. post-rx p-values*within arms | p = 0.86 | p = 0.007 | -- |
| Second hour insulin interval secretion | |||
| Pre-treatment slope | −728.2 | −383.6 | 0.78 |
| Post-treatment slope | −186.8 | 442.5 | 0.003 |
| Paired pre- vs. post-rx p-values*within arms | p = 0.38 | p = 0.03 | -- |
| Insulin interval secretion (2 hr) | |||
| Pre-treatment slope | −1245.0 | −1024.0 | 0.95 |
| Post-treatment slope | −1037.4 | 1085.8 | 0.0004 |
| Paired pre- vs. post-rx p-values*within arms | p = 0.80 | p = 0.01 | -- |
where diff = (post-rx slope) – (pre-rx slope)
*
p-values based on Wilcoxon signed rank (paired) test comparing the pre- vs. post-rx slopes by subject; evaluation of how much changes in these measures changed pre- vs. post-rx by subject and across those subjects in each treatment arm.