Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

• Evolution of fasting plasma glucose
• Evolution of insulin dose and body weight
• Hypoglycemia incidence
• Safety
• Patients satisfaction when they change their insulin for HOE901-U300

The total study duration per patient is approximately 28 weeks.

Inclusion criteria :

• Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist
• HbA1c > 7.5%

Exclusion criteria:

• Patients with high dose of insulin (>1.2 U/kg)
• Use of prandial insulin
• Change of dose of antidiabetic drugs within the last 8 weeks
• Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org