eleonor study: insulin glulisine in type 2 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 2

Summary: * the primary objective of the present study is to verify the superiority of telecare program vs. standard smbg program in terms of mean hba1c value (- 0,5%) at end-point. * the secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months * patients having bmi \> 25 kg/m2; * patients having a hba1c ≥ 7.5 % and ≤ 11 % * female patients must be menopausal, surgically sterile, or using effective contraceptive measures; * female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period. exclusion criteria: * patients diagnosed with type 1 insulin dependent diabetes mellitus; * history of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia; * active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation); * impaired renal function * impaired liver function * history of hypersensitivity to insulin or insulin analogues or any of the excipients in the insulin glulisine and insulin glargine formulation * history of hypersensitivity to metformin; * pregnant or breast-feeding women, or women planning to become pregnant during the study; * failure to use adequate contraception (women of current reproductive potential only); * any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases; * history of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse; * night shift workers; * receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry; * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; * treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol; * any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study; * subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures; * subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol; * previous enrolment in the present study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.