When we assessed incidence of hypoglycemia and its rate with various patient characteristics in insulin-naïve patients, there was no statistically significant difference in sub-groups such as sex, BMI, duration of diabetes, renal disorder not due to diabetes, baseline HbA1c, FPG, OADs prescribed prior to and during study, and compliance to diet and exercise (data not shown). The gene discussed is INS; the disease is diabetes mellitus.