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.
Ying DuLeili GaoXinhua XiaoXin HouLinong JiPublished in: Diabetes, obesity & metabolism (2022)
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.
Keyphrases
- double blind
- placebo controlled
- study protocol
- clinical trial
- phase iii
- phase ii
- open label
- randomized controlled trial
- heavy metals
- end stage renal disease
- ejection fraction
- phase ii study
- chronic kidney disease
- healthcare
- newly diagnosed
- squamous cell carcinoma
- emergency department
- nuclear factor
- rectal cancer
- health information
- risk assessment
- patient reported outcomes
- patient reported
- adverse drug