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Clinical Trial 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.


Clinical Trial Description

A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.

Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04390295
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact WENG Jianping, professor
Phone 86-020-85250217
Email wjianp@mail.sysu.edu.cn
Status Recruiting
Phase Phase 3
Start date November 2, 2017
Completion date May 2020

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