Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
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 ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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