Primary Objective: To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) \< 7%. Secondary Objectives: The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c \<7.0% in patients achieving their FPG target. The percentage of HbA1c \<7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast \<10 mmol/L).
The study duration for each patient will be 27 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
947
Pharmaceutical form: solution Route of administration: subcutaneous
Investigational Site Number 156053
Anshan, China
Investigational Site Number 156001
Beijing, China
Investigational Site Number 156002
Beijing, China
Investigational Site Number 156006
Beijing, China
Investigational Site Number 156013
Changchun, China
Investigational Site Number 156014
Percentage of patients with HbA1c <7% achievement
Time frame: 24 weeks
Percentage of patients achieving HbA1c <=6.5%
Time frame: 24 weeks
Percentage of patients achieving FPG target with HbA1c <7%
Time frame: 24 weeks
Percentage of patients achieving HbA1c <7% without hypoglycemia
Time frame: 24 weeks
Percentage of patients achieving the FPG target without hypoglycemia
Time frame: 24 weeks
Percentage of patients achieving FPG target
Time frame: 24 weeks
Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L)
Time frame: 24 weeks
Change from baseline in HbA1c
Time frame: Baseline to 24 weeks
Change in FPG
Time frame: 8 weeks to 24 weeks
Change in PPG
Time frame: Baseline to 24 weeks
Change in insulin doses in each arm
Time frame: 1 week to 24 weeks
Change in body weight in each treatment arm
Time frame: Baseline to 24 weeks
Percentage of patients experienced hypoglycemic events
Time frame: 24 weeks
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Changchun, China
Investigational Site Number 156022
Changde, China
Investigational Site Number 156017
Changsha, China
Investigational Site Number 156034
Changzhou, China
Investigational Site Number 156023
Chenzhou, China
...and 34 more locations