TABLE 2

Trial design

Number of subjects
• Aim to include sufficient numbers of subjects to enable stratification
Duration of trial
• Efficacy should be evaluated at a minimum of 2 years
Factors that influence outcome measures• Aim for tight control (e.g., as close to normal HbA1c as possible without causing hypoglycemia)

• Randomize, placebo-control, and double-mask subjects in phase II and III trials