Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period. ;
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