Status:
COMPLETED
ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-70 years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00272064
Start Date
October 1 2005
End Date
May 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Milan, Italy