A Model-Informed Approach to Accelerate the Clinical Development of Janagliflozin, an Innovative SGLT2 Inhibitor.

Ling SongXiaoxu WangJingfang SunXinyu HuHaiyan LiPei HuDongyang Liu

Published in: Clinical pharmacokinetics (2023)

The application of MIDD strategy adequately supported the decision making at each stage of janagliflozin development process. A waiver of Phase 2 study was successfully approved for janagliflozin based on these model-informed results and suggestions. This MIDD strategy of janagliflozin could be further utilized to support the clinical development of other SGLT2 inhibitors.

Keyphrases

decision making
open label
double blind
study protocol
placebo controlled