drugset / Trial / NCT00272064
ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
| Background | Metformin | Small molecule | 1000 mg | Oral |