Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

• Assess effectiveness in achieving glycemic goal measured by HbA1c;
• Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
• Assess requirement for intensification of therapy by additional antidiabetics.
• Assess incidence of hypoglycemia;
• Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
• Assess change in body weight.

Patients will be observed for one year

Inclusion criteria :

• Signed patient informed consent;
• Type 2 diabetes mellitus;
• Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
• Hemoglobin A1c (HbA1c) >7.0 % and ≤11% within 3 months of study baseline;
• Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria:

• Diabetes mellitus other than type 2;
• Contraindication to insulin glargine U300 according to local product labelling;

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

Insulin-naïve patients with type 2 diabetes mellitus and Oral Antidiabetic Drug failure

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