Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

Summary

Primary objective: * Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c\<7% and/or a final decrease of HbA1c\>15% compare to the basal value (HbA1c final - HbA1c basal). Secondary objectives: * Determination of the predictive criterion of HbA1c final, * Determination of the predictive criterion of weight variation, * Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders), * Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value). Safety: * Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Timeline

Start

2003-04

Primary completion

2004-09

Completion

2005-10

Drugs

Indications