The ITT analysis, conducted as a sensitivity test,
showed similar results to that of the per protocol analysis.
The intervention group demonstrated a significant
reduction in HbA1c (−0.14% (0.2%)) while no reduction
was seen in the control group (+0.03% (0.2%));
p value for difference between groups was 0.029. In addition,
the ITT analysis also showed that both groups had
non-significant reductions in mean weight (intervention:
−0.21 kg (0.9 kg), control: −0.08 kg (1.1 kg)) and BMI
(intervention: −0.09 kg/m2 (0.4 kg/m2), control:
−0.02 kg/m2 (0.5 kg/m2)) from baseline to post-trial,
with a greater decrease among the intervention group.