drugset / Trial / NCT00272064

ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

NCT00272064

Phase 3 Completed 352 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2005-10
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous
Subject insulin glargine Protein / enzyme biologic Subcutaneous
Background Metformin Small molecule 1000 mg Oral