To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
393
HR17031 injection
insulin glargine
Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
Changes in HbA1c from baseline to week 26
Time frame: from baseline to week 26
Proportion of subjects achieved HbA1c<7.0% at week 26
Time frame: at week 26
Change in body weight from baseline to week 26
Time frame: from baseline to week 26
Proportion of subjects achieved HbA1c<7.0% and no weight gain at week 26
Time frame: at week 26
Daily Insulin dose at week 26
Time frame: at week 26
The proportion of subjects achieved HbA1c≤6.5% at week 26
Time frame: at week 26
Changes in FPG from baseline to week 26
Time frame: from baseline to week 26
Hypoglycemic event from screening to week 27
Time frame: from screening to week 27
Adverse events from screening to week 27
Time frame: from screening to week 27
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