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A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM

NCT04218734 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2021-06-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kun Lou · Department of medicine, CSPC clinical development division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2021-06-03
Completion
2021-06-03

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218734 on ClinicalTrials.gov