ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Metformin

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.