Primary Objective: * To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure. Secondary Objective: * To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Pharmaceutical form:solution Route of administration: subcutaneous
Administrative office
Tokyo, Japan
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Time frame: 24 weeks
Responder rate (HbA1c levels <7%) without severe hypoglycemia
Time frame: 24 weeks
Responder rate (HbA1c levels <6.5% and <7%)
Time frame: 24 weeks
Changes of fasting plasma glucose (FPG) levels from baseline
Time frame: 24 weeks
Changes of beta cell marker: C-peptide from baseline
Time frame: 24 weeks
Changes of Lipid profile: Lipid profile from baseline
Time frame: 24 weeks
Weight change from baseline
Time frame: 24 weeks
Total insulin dose (per kg body weight)
Time frame: 24 weeks
Evaluation of patient's treatment satisfaction
Time frame: 24 weeks
Number of patients with hypoglycemia
Time frame: up to 24 weeks
Number of patients with treatment-emergent adverse events
Time frame: up to 24 weeks
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