TABLE 1

Inclusion criteria

Diagnosis of diabetes
• According to American Diabetes Association criteria
Age• Phase I trials ≥ age 18 years

• Phase II, and III trials ≤ age 35 years
Autoantibodies
• One of four to GAD65, insulin (if on insulin <2 weeks), IA2, or ICA
Start of therapy in relationship to diabetes diagnosis• Baseline MMTT peak C-peptide ≥0.2 pmol/l

• If early-onset trial, subjects to be enrolled between 2 and 12 weeks from diagnosis