Clinical trial NCT00272064: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-04
Enrollment: 352
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Changes of glycosilated haemoglobin (HbA1c)
timeFrame: At least 12 weeks from baseline (visit 3)
Secondary outcomes:
measure: Changes in fasting plasma glucose
timeFrame: At each visit
measure: Changes in plasma insulin levels
timeFrame: At each visit
measure: Change of Self-monitoring of Blood Glucose (SMBG)
timeFrame: for the total study duration
measure: Mean Amplitude Glucose Excursion (MAGE)
timeFrame: for the total study duration
measure: Change in lipid profile
timeFrame: V1 (screening) and V5 (end of treatment)
measure: Body weight - Body Mass Index
timeFrame: V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up)
measure: Total daily dose of insulins (glargine and glulisine)
timeFrame: At each visit (starting from V2 for glargine and from V3 for glulisine)
measure: Health related Quality of Life
timeFrame: V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment)
measure: Hypoglycemic episodes
timeFrame: for the total study duration
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: PAIZIS GEORGES, MD
role: STUDY_DIRECTOR
References:
citation: 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.