Type 2 Diabetes Mellitus Clinical Trial
Official title:
Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients
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.
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
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