A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

• Targeted HbA1c;
• Targeted fasting self- monitoring blood glucose (SMBG);
• Hypoglycemic events;
• Adverse events;
• Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
• Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.

The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

Inclusion criteria :

• Adult patients with type 2 diabetes mellitus (≥18 years of age).
• Type 2 diabetes mellitus diagnosis ≥1 year.
• Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
• Stable antidiabetic treatment for at least 3 months.
• Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).
• Signed informed consent obtained.

Exclusion criteria:

• Age <18 years old.
• Type 1 diabetes mellitus.
• Having secondary type 2 diabetes mellitus.
• Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
• History of hypoglycemia unawareness.
• Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
• Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
• Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
• Pregnant or lactating women.
• Participation in another clinical trial.

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