Status:
COMPLETED
Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
Primary objective: To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with O...
Eligibility Criteria
Inclusion
- Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
- 5 ≤ HbA1c ≤ 9.5%
- FPG ≥6.7 mmol/L
- History of Diabetes mellitus ≤10 years
- Premix insulin daily dosage ≤ 50 IU/Day
Exclusion
- Type 1 Diabetes Mellitus
- Former treated on TZD
- Pregnancy / Lactation
- Creatine ≥1.5 mg/dl
- Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range
- Hormone therapy,
- Acute status of Diabetes complications
- Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.
- Allergic to insulin glargine or any ingredient
- Participation in another clinical trial within 3 months
- 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 :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00693771
Start Date
April 1 2008
End Date
July 1 2009
Last Update
January 25 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China