insulins glargine and glulisine strategy versus premixed insulin strategy: a comparative study

Conditions: Diabetes Mellitus, Type 2

Summary: 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 \ percentage of patients who reach the target of hba1c \ 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


Eligibility criteria:
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.