ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Study Overview
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Brief Summary
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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).

Official Title
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Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin glulisine
* Drug: Insulin glargine
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Telecare system | Drug: Insulin glulisine<br>* 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<br>Drug: Insulin glargine<br>* individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous<br>Drug: Metformin<br>* 1000 mg b.i.d, since the qualification phase, oral<br>|
| Other: 2<br>Self Monitoring Blood Glucose (SMBG)system. | Drug: Insulin glulisine<br>* 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<br>Drug: Insulin glargine<br>* individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous<br>Drug: Metformin<br>* 1000 mg b.i.d, since the qualification phase, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of glycosilated haemoglobin (HbA1c) |  | At least 12 weeks from baseline (visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting plasma glucose |  | At each visit | 
| Changes in plasma insulin levels |  | At each visit | 
| Change of Self-monitoring of Blood Glucose (SMBG) |  | for the total study duration | 
| Mean Amplitude Glucose Excursion (MAGE) |  | for the total study duration | 
| Change in lipid profile |  | V1 (screening) and V5 (end of treatment) | 
| Body weight - Body Mass Index |  | V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up) | 
| Total daily dose of insulins (glargine and glulisine) |  | At each visit (starting from V2 for glargine and from V3 for glulisine) | 
| Health related Quality of Life |  | V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment) | 
| Hypoglycemic episodes |  | for the total study duration |