drugset / Trial / NCT04161430
A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce hemoglobin A1C levels in T2DM subjects.
Timeline
- Start
- 2020-01-02
- Primary completion
- 2022-06-27
- Completion
- 2022-06-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DBPR108 | Small molecule | 100 mg | — |
| Comparator | Sitagliptin | Small molecule | 100 mg | — |