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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

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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… Click to show full abstract

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.

Keywords: glucokinase activator; study; placebo; phase

Journal Title: Diabetes
Year Published: 2022

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