Table 4.
Mean change from baseline to last observation in exploratory secondary endpoints (efficacy population, n = 34).
| Parameter | Mean change from baseline to last observation | p-value |
|---|---|---|
| Fructosamine (μmol/L) | -13.92 | 0.002 |
| HOMA-IR a | -1.58 | 0.064 |
| ALT (U/L) | -10.62 | < 0.001 |
| AST (U/L) | -4.94 | 0.001 |
| Serum osteocalcin (μg/L) | 3.00 | < 0.01 |
| Absolute eosinophils (109/L) | 0.05 | 0.006 |
| aPTT (sec) | 1.45 | 0.046 |
| Factor VIII (%) | -18.94 | 0.022 |
| Platelet count (109/L) | -68.82 | < 0.001 |
| BDI-II Total score | -3.48 | 0.004 |
| Cushing QoL score | 7.13 | 0.002 |
| Trail Making Test Part A – Total time to complete test (sec) | -4.13 | 0.003 |
| Trail Making Test Part B – Total time to complete test (sec) | -24.69 | < 0.001 |
p-values for the mean change from baseline to last observation are from the Wilcoxon signed-rank test.
a
A significant difference was observed in the high-dose treatment group (mean change -3.2, p = 0.033).
ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; AUC, area under the curve; BDI, Beck Depression Inventory; HOMA-IR, homeostatic model assessment for insulin resistance; QoL, quality of life.