A multicentre, randomized, double‐blind, 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

AIM: To report the rationale for using PB-201, a partial glucokinase activator (GKA), for a Phase 3 study (NCT05102149) assessing its efficacy and safety in a Chinese population and to describe the design of this GKA Phase 3 trial, the first to involve both an active control and a placebo control arm. MATERIALS AND METHODS: This is an ongoing, multicentre, randomized, double-blind, three-arm placebo and active control study to be carried out among 672 Chinese treatment-naive participants with type 2 diabetes mellitus (T2DM) to assess the efficacy and safety of PB-201 for approximately 60 weeks, including a screening period and a safety follow-up period. RESULTS: The primary objective of this study was to monitor change in glycated haemoglobin levels with PB-201 in treatment-naive T2DM participants from baseline to 24 weeks in comparison with vildagliptin and placebo. The key secondary objective was to assess the efficacy and safety of PB-201 following treatment for a time period of 52 weeks. CONCLUSION: This pivotal study will offer critical information regarding the efficacy and safety of PB-201 in Chinese treatment-naive T2DM participants that would help to establish robust evidence for the benefit-risk evaluation of this drug.