drugset / Trial / NCT04161430

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients

NCT04161430

Phase 3 Completed 766 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject DBPR108 Small molecule 100 mg
Comparator Sitagliptin Small molecule 100 mg