01Nov 2022
A Multi‐center, Randomized, Double‐Blinded, Parallel, Active and Placebo‐Controlled Phase 3 Clinical Study of the glucokinase activator PB‐201 in Treatment‐naive Patients with Type 2 Diabetes Mellitus: A Study Protocol

A Multi‐center, Randomized, Double‐Blinded, Parallel, Active and Placebo‐Controlled Phase 3 Clinical Study of the glucokinase activator PB‐201 in Treatment‐naive Patients with Type 2 Diabetes Mellitus: A Study Protocol

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.

  • #endo-diabetology

Like

Save

Share