Type 2 Diabetes
Conditions
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
Interventions
DRUGLantus (insulin glargine) + Glucophage (Metformin)
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed