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ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

NCT00272064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2009-12-07

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glulisine

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

DRUG

Insulin glargine

individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous

DRUG

Metformin

1000 mg b.i.d, since the qualification phase, oral

Sponsors & Collaborators

Principal Investigators

  • PAIZIS GEORGES, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00272064 on ClinicalTrials.gov