The effect of TTP399 on HbA_1c, insulin dosing, and safety in parts 1 and 2 of the SimpliciT1 study. A and B: Mean change in HbA_1c from baseline to week 12 in parts 1 (A) and 2 (B). C: Percentages of responders in parts 1 and 2 are shown. Part 1 data were analyzed by the responder criteria outlined in the statistical analysis plan from parts 1 and 2. D: Change in HbA_1c is plotted against change in total insulin. The positive correlation between reduction in HbA_1c and reduction in total insulin was significant (P = 0.008). Data analyzed comprise the full analysis set. E: Cumulative number of episodes of severe or symptomatic hypoglycemia in part 2. Post hoc analysis demonstrated nominal P < 0.05. F: Cumulative incidence of β-hydroxybutyrate >0.4 mmol/L. Data in F represent the pooled cohort from parts 1 and 2 of the study. BOHB, β-hydroxybutyrate.