Dataset from A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

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