This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.
Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
570
Solution for injection Subcutaneous injection
Investigational Sites
China, China
Mean change in HbA1c from baseline to week 24
Time frame: Baseline to Week 24
Mean change in HbA1c from baseline to week 12 and week 36
Time frame: Baseline to Week 12 and 36
Percentage of participants achieving HbA1c target <7%
Time frame: at Week 12, 24 and 36
Percentage of participants achieving HbA1c target <7% without hypoglycemic events
Time frame: at Week 12 and 24
Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36
Time frame: Baseline to Week 12, 24 and 36
Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24
Time frame: Baseline to Week 12 and 24
Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24
Time frame: Baseline to Week 12 and 24
Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36
Time frame: Baseline to Week 12, 24 and 36
Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36
Time frame: Baseline to Week 12, 24 and 36
Number of hypoglycemic events per patient-year
Time frame: Baseline to Week 12, 24 and 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants with adverse events
Time frame: Baseline to Week 24 and 36
Mean change in body weight from baseline to Week 12 and Week 24
Time frame: Baseline to Week 12 and 24