Primary Objective:

To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.

Secondary Objectives:

• To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7% without hypoglycemia.
• To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.
• To assess safety in term of occurrence of moderate/severe hypoglycemia.
• To assess daily blood glucose (BG) variation.
• To assess patient satisfaction.

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study

Inclusion criteria :

• Patients with age between 18 and 70 years.
• Hemoglobin A1c>7.5%, and ≤11%.
• Fasting plasma glucose >7 mmol/L.
• Fasting C peptide >1 ng/mL.
• Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria).
• Continuous treatment with stable doses of metformin (≥1 g/day) and 1 oral antihyperglycemic drug (at least half maximum dose) for more than 3 months prior to screening.
• Body mass index ≥21 kg/m2, and <40 kg/m2.

Exclusion criteria:

• More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery.
• Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake).
• History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months.
• History of sensitivity to the study drugs or to drugs with a similar chemical structure.
• Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
• Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 12 months.
• Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy.
• Acute infections which may affect BG control within the past 4 weeks.
• Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening.
• Impaired renal function, defined as but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (>2 g/day).

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