Status:
COMPLETED
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-69 years
Phase:
PHASE4
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 H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00653302
Start Date
April 1 2003
End Date
October 1 2005
Last Update
December 3 2008
Active Locations (1)
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1
Sanofi-aventis administrative office
Paris, France