Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00653302
Brief 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
Study:
NCT00653302
Study Brief:
Protocol Section:
NCT00653302