ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Insulin glulisine; Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272064

EudraCT # : 2004-002731-62

HMR1964A_3514

Details and patient eligibility

About

• 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).

Enrollment: 352 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

1

Other group

Description:

Telecare system

Treatment:

Drug: Metformin

Drug: Insulin glulisine

Drug: Insulin glargine

2

Other group

Description:

Self Monitoring Blood Glucose (SMBG)system.

Treatment:

Drug: Metformin

Drug: Insulin glulisine

Drug: Insulin glargine