Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of
change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese
patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting
plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose
(SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of
hypoglycemia