Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Inclusion criteria: * Type 2 diabetes diagnosed for more than 1 year * Insulin naïve * Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months * HbA1c ≥ 7.0 % and ≤ 10.5% * Body mass index (BMI) ≤ 40 kg/m2 * Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary * Willingness and ability to comply with the study protocol * Signed informed consent obtained prior any study procedure Exclusion criteria: * Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry * Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week) * Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake) * Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) * Hospitalized patient (except for routine diabetes check-up) * Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry * History of sensitivity to the study drugs or to drugs with a similar chemical structure * Impaired renal function: creatinine clearance \< 60ml/min * Impaired liver function (ALT, AST \> 3 x upper limit of normal range) * Severe gastro-intestinal disease * Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry * Likelihood of requiring treatments during the study which are not permitted * Treatment with an investigational product in the 30 days prior to study entry * Alcohol or drug abuse within the last 5 years The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.