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Clinical Trial Details

Trial ID: L5068
Source ID: NCT00272064
Associated Drug: Insulin Glulisine
Title: ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin glulisine|DRUG: Insulin glargine|DRUG: Metformin
Outcome Measures: Primary: Changes of glycosilated haemoglobin (HbA1c), At least 12 weeks from baseline (visit 3) | Secondary: 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
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 352
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-10
Completion Date: 2008-05
Results First Posted:
Last Update Posted: 2009-12-07
Locations: Sanofi-Aventis Administrative Office, Milan, Italy
URL: https://clinicaltrials.gov/show/NCT00272064