Type 2 Diabetes Clinical Trial
Official title:
Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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