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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
Peking Union Medical College Hospital
Beijing, China
Change in HbA1c (%) from baseline to week 24
The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo
Time frame: baseline, 24 weeks
Percentage of HbA1c ≤ 6.5%
Proportion of patients achieving HbA1c ≤ 6.5% at week 24
Time frame: 24 weeks
Percentage of HbA1c ≤ 7%
Proportion of patients achieving HbA1c ≤ 7% at week 24
Time frame: 24 weeks
Change in HbA1c (%) from baseline to week 12
The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo
Time frame: baseline, 12 weeks
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24
The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo
Time frame: Baseline, 12 weeks and 24 weeks
Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24
The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo
Time frame: Baseline, 12 weeks and 24 weeks
Change in body weight from baseline to week 12 and week 24
The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo
Time frame: Baseline, 12 weeks and 24 weeks
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