Status:
COMPLETED
Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary objective: * To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients Secondary objectives: * To assess the forced titration on physician an...
Eligibility Criteria
Inclusion
- T2 insulin naïve patients
- Patients whom their physician is considering initiation of Lantus treatment
- Poor glycemic control 7,5 %10 %
- T2 treatment with OADs more than 3 months
- BMI\<40 kg/m2
Exclusion
- Impaired renal function (Cr\>2mg/dl or current renal dialysis)
- Acute or chronic metabolic acidosis
- Active liver disease or serum ALT or AST \>2,5 than normal
- History of hypoglycemia unawareness
- Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
- Pregnancy, breast feeding
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00701831
Start Date
May 1 2008
End Date
October 1 2010
Last Update
November 4 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)