Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
Participant gender:
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