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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Lantus (insulin glargine) + Glucophage (Metformin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known type 2 diabetes for at least 2 years No history of Ketoacidosis BMI> 25 & <35 kg/m2 Type 2 diabetes treated with oral bi or tritherapy for at least 6 months With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC), and metformin at minimal posology 1700mg/day (1320 mg of metformin), HbA1c >= 7.5 and <11% for 2 different dosages during the last year Exclusion Criteria: Type 1 diabetes Glucophage intolerability Pregnancy Breast feeding Partial pancreatectomy Hypersensitivity to insulin glargine excipient Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient Hepatitis with transaminases >3ULN Pre-proliferative or proliferative retinopathy Acute cardiovascular accident within the last 6 months Previous treatment with insulin within the last 6 months before randomization

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lantus once a day plus Glucophage 1000mg, twice a day per os | Drug: Lantus (insulin glargine) + Glucophage (Metformin)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal). |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the predictive criterion of HbA1c final |  | During the study conduct | 
| Determination of the predictive criterion of weight variation |  | During all the study conduct | 
| HbA1c and weight variations (final value - basal value) |  | during the study | 
| AE/SAE evaluation |  | from the informed consent signed up to the end of the study |