
Despite the availability of multiple classes of antidiabetic medications, improving glucose management remains an unmet medical need. Glucokinase activators (GKAs) are an emerging new class of treatment for Type 2 Diabetes Mellitus (T2DM). This study reports the study design and rationale of using PB‐201, a partial GKA, for a phase 3 study (NCT05102149), assessing its efficacy and safety in the Chinese population. This study is the first GKA phase 3 trial with a design involving an active control arm in addition to a placebo control arm. This pivotal study will offer critical information regarding the efficacy and safety of PB‐201 in Chinese treatment-naive T2DM participants, which would help to establish robust evidence for the benefit‐risk evaluation of this drug.
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