The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
401
HR17031 injection
insulin glargine
Peking University People's Hospital
Beijing, Beijing Municipality, China
Change in HbA1c: Changes in HbA1c from baseline to week 26
Time frame: week 26
Proportion of subjects achieved HbA1c<7.0% at week 26
Time frame: at week 26
Change in body weight from baseline after 26 weeks of treatment
Time frame: 26 weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26
Time frame: week 26
Actual Daily Insulin dose at week 26
Time frame: week 26
Proportion of subjects achieved HbA1c≤6.5% at week 26
Time frame: week 26
Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment
Time frame: 26 weeks
Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26
Time frame: week 26
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Time frame: 12weeks
Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Time frame: 12weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
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Time frame: at week 26
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
Time frame: at week 26
Proportion of subjects achieved HbA1c<5.7% at week 26
Time frame: at week 26
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;
Time frame: week 26;
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment
Time frame: 26 weeks
Changes in HbA1c from baseline after 52 weeks of treatment
Time frame: 52 weeks
Changes in FBG from baseline after 52 weeks of treatment
Time frame: 52 weeks
Changes in body weight from baseline after 52 weeks of treatment
Time frame: 52 weeks
Proportion of subjects achieved HbA1c<7% at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7% without body weight gain at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<5.7% at week 52
Time frame: at week 52
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52
Time frame: week 52
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment
Time frame: 52 weeks
Actual Daily Insulin dose at week 52
Time frame: at week 52
Number of Treatment-emergent Hypoglycemic event from screening to week 53
Time frame: from screening to week 53
Number of Treatment-emergent Adverse Events from screening to week 53
Time frame: from screening to week 53
Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27
Time frame: at week 27