Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Summary
This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.
Timeline
- Start
- 2017-07-18
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
Outcome
Met primary endpoint
release “Phase III Monotherapy Trial (HMM0301) of Dorzagliatin Achieves Primary Efficacy Endpoint with 24-Week Topline Results” huamedicine.com ↗
release “Dorzagliatin has achieved its primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period” huamedicine.com ↗
release “SEED study include: Significant and long-lasting efficacy: ● There was a 1.07% HbA1c reduction from baseline in 24 weeks” huamedicine.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dorzagliatin | Small molecule | 75 mg | Oral |