Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

The study duration for each patient is 24 weeks +/- 1 week broken down as follows:

• Run-in phase: 8 weeks
• Follow - up Period: 16 weeks

The maximal possible time window during the study is +/- one week throughout the study.

Inclusion criteria

Run-in period:

• Type 2 diabetes
• HbA1c≥ 8.5% (in a test of the last month)
• Age above 21 years
• Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
• Signed informed consent form
• Patients who according to their physician are eligible to the study

Randomization:

• HbA1c > 7.5%
• FPG < 130 mg/dl

Exclusion criteria

• Type 1 diabetes
• Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
• Pregnant or breastfeeding women.
• Patients with allergy to insulin.
• Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
• Patients with mobility difficulties and/or difficulties communicating with the investigator

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