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Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes

NCT04390295 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-05-15

No results posted yet for this study

Summary

The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.

Conditions

Interventions

DRUG

Placebo

Once daily, 24 weeks

DRUG

SHR3824

Once daily, 52 weeks

DRUG

metformin

Three times daily, 52 weeks

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

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
2017-11-02
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT04390295 on ClinicalTrials.gov