ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

NCT ID: NCT00272064

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-05-31

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Telecare system

Group Type: OTHER

Insulin glulisine

Intervention Type: DRUG

individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous

Insulin glargine

Intervention Type: DRUG

individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous

Metformin

Intervention Type: DRUG

1000 mg b.i.d, since the qualification phase, oral

2

Self Monitoring Blood Glucose (SMBG)system.

Group Type: OTHER

Insulin glulisine

Intervention Type: DRUG

individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous

Insulin glargine

Intervention Type: DRUG

individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous

Metformin

Intervention Type: DRUG

1000 mg b.i.d, since the qualification phase, oral

Interventions

Insulin glulisine

individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous

Intervention Type: DRUG

Insulin glargine

individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous

Intervention Type: DRUG

Metformin

1000 mg b.i.d, since the qualification phase, oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

PAIZIS GEORGES, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Milan, , Italy

Countries

Italy

References

Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012 Feb;14(2):175-82. doi: 10.1089/dia.2011.0163. Epub 2011 Oct 20.

Reference Type: DERIVED

PMID: 22013886 (View on PubMed)

Other Identifiers

EudraCT # : 2004-002731-62

Identifier Type: -

Identifier Source: secondary_id

HMR1964A_3514

Identifier Type: -

Identifier Source: org_study_id