ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus. | RxWiki

ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Overview[ - collapse ][ - ]

Purpose	- 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).
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Insulin glulisine Drug: Insulin glargine Drug: Metformin
Phase	Phase 3
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00272064
First Received	January 2, 2006
Last Updated	December 4, 2009
Last verified	December 2009

Tracking Information[ + expand ][ + ]

First Received Date	January 2, 2006
Last Updated Date	December 4, 2009
Start Date	October 2005
Estimated Primary Completion Date	May 2008
Current Primary Outcome Measures	Changes of glycosilated haemoglobin (HbA1c) [Time Frame: At least 12 weeks from baseline (visit 3)] [Designated as safety issue: No]
Current Secondary Outcome Measures	Changes in fasting plasma glucose [Time Frame: At each visit] [Designated as safety issue: No] Changes in plasma insulin levels [Time Frame: At each visit] [Designated as safety issue: No] Change of Self-monitoring of Blood Glucose (SMBG) [Time Frame: for the total study duration] [Designated as safety issue: No] Mean Amplitude Glucose Excursion (MAGE) [Time Frame: for the total study duration] [Designated as safety issue: No] Change in lipid profile [Time Frame: V1 (screening) and V5 (end of treatment)] [Designated as safety issue: No] Body weight - Body Mass Index [Time Frame: V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up)] [Designated as safety issue: No] Total daily dose of insulins (glargine and glulisine) [Time Frame: At each visit (starting from V2 for glargine and from V3 for glulisine)] [Designated as safety issue: No] Health related Quality of Life [Time Frame: V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment)] [Designated as safety issue: No] Hypoglycemic episodes [Time Frame: for the total study duration] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Official Title	Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
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).
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: 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 Drug: Insulin glargine individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous Drug: Metformin 1000 mg b.i.d, since the qualification phase, oral
Study Arm (s)	Other: 1 Telecare system Other: 2 Self Monitoring Blood Glucose (SMBG)system.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	352
Estimated Completion Date	May 2008
Estimated Primary Completion Date	May 2008
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.
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT00272064
Other Study ID Numbers	HMR1964A_3514
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: PAIZIS GEORGES, MD Sanofi
Verification Date	December 2009

Locations[ + expand ][ + ]