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

A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents

Primary Objective:

To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.

Secondary Objectives:

To assess the effect of insulin glargine in comparison with premixed insulin on :

• Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)
• Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles
• Evolution of weight
• Hypoglycemia occurrence
• Dose of insulins
• Evolution of liver function
• Overall safety

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.