Trials / Completed
CompletedNCT04218734
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 214 (actual)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DBPR108 | DBPR108: 100 mg, once daily for 24 weeks. |
| DRUG | metformin hydrochloride | metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks. |
| DRUG | placepo | placebo:100 mg, once daily for 24 weeks. |
Timeline
- Start date
- 2020-01-14
- Primary completion
- 2021-06-03
- Completion
- 2021-06-03
- First posted
- 2020-01-06
- Last updated
- 2021-06-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04218734. Inclusion in this directory is not an endorsement.