Endpoints
The primary endpoint was endogenous insulin production, as assessed according to the 2-h serum C-peptide AUC during an MMTT at 12 months. The AUC was calculated at each visit using the trapezoidal rule on five measurements collected during the 2-h test (at 0, 15, 30, 60 and 90 min, respectively). Secondary endpoints included a preserved peak C-peptide level greater than 0.2 pmol ml