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

Sanofi280 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Time frame: During the study conduct

Secondary Outcomes

Determination of the predictive criterion of HbA1c final

Time frame: During the study conduct

Determination of the predictive criterion of weight variation

Time frame: During all the study conduct

HbA1c and weight variations (final value - basal value)

Time frame: during the study

AE/SAE evaluation

Time frame: from the informed consent signed up to the end of the study