Primary Objective: To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved. Secondary Objectives: * To assess efficacy in terms of percentage of patients achieving HbA1c \<7% and HbA1c \<7% without hypoglycemia. * To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) \<7 mmol/L and FPG \<7 mmol/L without hypoglycemia. * To assess safety in term of occurrence of moderate/severe hypoglycemia. * To assess daily blood glucose (BG) variation. * To assess patient satisfaction.
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Pharmaceutical form: tablet Route of administration: oral administration
Pharmaceutical form: tablet Route of administration: oral administration
Pharmaceutical form: tablet or capsule Route of administration: oral administration
CHINA
China, China
Change in hemoglobin A1c (HbA1c)
Change in HbA1c from baseline to week 24
Time frame: Baseline to Week 24
Patients with fasting plasma glucose (FPG) <6.1 mmol/L
Percentage of patients with FPG \<6.1 mmol/L at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with FPG <6.1 mmol/L without hypoglycemia
Percentage of patients with FPG \<6.1 mmol/L without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with FPG <7 mmol/L
Percentage of patients with FPG \<7 mmol/L at week 12 and week 2
Time frame: At Week 12 and Week 24
Patients with FPG <7 mmol/L without hypoglycemia
Percentage of patients with FPG \<7 mmol/L without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with HbA1c <7%
Percentage of patients with HbA1c \<7% at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with HbA1c <7% without hypoglycemia
Percentage of patients with HbA1c \<7% without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Hypoglycemic events
Incidence of hypoglycemia during treatment period
Time frame: Baseline to Week 24
Change in FPG
Change in FPG from baseline to week 24
Time frame: Baseline to Week 24
Change in body weight
Change in body weight from baseline to week 24
Time frame: Baseline to Week 24
Insulin dose
Total daily insulin dose at week 24
Time frame: At Week 24
Daily BG variation at week 24
Daily blood glucose (BG) variation at week 24
Time frame: At Week 24
European quality of life - 5 dimensions (EQ-5D)
Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem.
Time frame: Baseline to Week 24
Subgroup analysis
Subgroup analysis of control rate of HbA1c \<7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period
Time frame: At week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.