Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs). Secondary Objective: * To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) \<7%. * To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (\<5.6, \<6.1, and \<7.0 mmol/L). * To assess the changes in HbA1c, FPG, and postprandial glucose (PPG). * To evaluate the insulin doses change. * To evaluate the weight change. * To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence. * To descriptively evaluate the safety profile. * To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration). * Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to: * Age * Duration of diabetes * Baseline treatment (OAD) * Baseline HbA1c, FPG and PP
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
892
Pharmaceutical form: solution Route of administration: subcutaneous injection
Pharmaceutical form: table or capsule Route of administration: oral administration
Pharmaceutical form: table or capsule Route of administration: oral administration
Unnamed facility
China, China
Percentage of patients with at least one episode of hypoglycemia
Time frame: 16 weeks
Percentage of patients achieving HbA1c <7%
Time frame: 16 weeks
Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Time frame: 16 weeks
Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Time frame: 16 weeks
Change from baseline in HbA1c
Time frame: Baseline, 16 weeks
Change from baseline in Fasting Plasma Glucose
Time frame: Baseline, 16 weeks
Change from baseline in Post Prandial Glucose
Time frame: Baseline, 16 weeks
Change in body weight
Time frame: Baseline, 16 weeks
- Change in insulin dose
Time frame: Baseline, 16 weeks
Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L])
Time frame: Baseline, 16 weeks
Number of nocturnal hypoglycemic events
Time frame: Baseline, 16 weeks
Number of severe hypoglycemic events
Time frame: Baseline, 16 weeks
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