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
Abstract
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\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
Conditions: Type 2 Diabetes.
Primary outcome: % of responders with HbA1c15% compare to the basal value (HbA1c final - HbA1c basal)..
Enrollment: 280 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 280 participants or records.
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