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
Study context
- Population
- Chinese treatment-naive participants with T2Dplanned
- Participants
- 672 participants
- Planned comparison
- PB-201 vs vildagliptin vs placebo
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- 24 weeks
Methodological detailsmulticentre, double-blind, three-arm, placebo-controlled, active-controlled, phase 3, ongoing, Study duration ≈60 weeks, including screening and safety follow-up periods, Key secondary objective: efficacy and safety of PB-201 after 52 weeks of treatment
- Multicentre
- Double-blind
- Three-arm
- Placebo-controlled
- Active-controlled
- Phase 3
- Ongoing
- Study duration ≈60 weeks, including screening and safety follow-up periods
- Key secondary objective: efficacy and safety of PB-201 after 52 weeks of treatment
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
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. Diabetes Obes Metab. Published 21 November 2022. doi:10.
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