Primary Objective: \- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: * To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments; * To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c)); * To compare the occurrence of hypoglycemia between the 2 treatments; * To assess the safety and tolerability of a new formulation of insulin glargine.
66 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Investigational Site Number 392001
Kumamoto, Japan
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Time frame: Baseline, Day 28, Day 56
Hypoglycemia categorized by the definition of American Diabetes Association
Time frame: Up to Day 56
Change in fasting plasma glucose from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
Change in HbA1c from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
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