Overview

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

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Metformin
Criteria
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