Dataset from A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin
A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

- Percentage of participants with at least one severe and/or confirmed (by plasma glucose
≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning

- Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or
confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event

- Percentage of participants with at least one severe and/or confirmed (by plasma glucose
≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day

- HbA1c change