ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Metformin

• Registration Number: NCT00272064
• Lead Sponsor: Sanofi

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 available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-02
• Study First Submitted QC: 2006-01-02
• Study First Posted: 2006-01-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Insulin glulisine	Telecare system
1	Insulin glargine	Telecare system
2	Metformin	Self Monitoring Blood Glucose (SMBG)system.
1	Metformin	Telecare system
2	Insulin glulisine	Self Monitoring Blood Glucose (SMBG)system.
2	Insulin glargine	Self Monitoring Blood Glucose (SMBG)system.

Primary Outcome Measures

Name	Time	Method
Changes of glycosilated haemoglobin (HbA1c)	At least 12 weeks from baseline (visit 3)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇹 Milan, Italy