The primary outcome for the TIAD
study is change in HbA1c level from baseline to week 48 in the intent-to-treat
(ITT) population. In this analysis, we will include 283 patients,
137 in the placebo arm, and 146 in the athelis arm. Of the 286 randomized
as shown in Figure 1, three HbA1c baseline results are missing in
the placebo arm and must be excluded. Two were randomized but dropped
out of the trial before blood was drawn. One is missing due to a
lab error. The median follow-up time in both groups is 48 weeks with
a minimum of 0 and a maximum of 48.
We will use a repeated measures
mixed model as described above.
Tables 12.3 and 12.4 below show
the information we will present.