In this double-blind, placebo-controlled 12-week trial, the baseline mean HbA1c for the groups treated with TTP399 and placebo was 7.3% and 7.4%, respectively.
Patients treated with TTP399 showed a statistically significant mean reduction in HbA1c of 0.6% at 12 weeks, while the group treated with placebo showed a mean increase in HbA1c of 0.1%, resulting in a mean difference of 0.7% in the TTP399 group relative to the placebo group (p=0.03).
At the same time, trends toward decreased insulin usage were observed in the group treated with TTP399.
Patients in this study received insulin adjustments to optimise glucose levels.
As a result, the primary analysis included a responder analysis in which a 'treatment responder' was defined as a patient who had a decrease in HbA1c at Week 12, no abnormal lactate or ketones detected in blood or urine during the study, and no increased time in Level 2 hypoglycemia (blood glucose
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