Status:
COMPLETED
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.
Detailed Description
Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of ...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus for at least 1 year
- treated with oral antidiabetic agents or insulin at stable doses for at least 3 months
- HbA1c between 6 and 12% inclusive
- baseline retinopathy severity not to exceed 53/\<53 on the ETDRS scale
- unlikely to require laser surgery or vitrectomy within upcoming year
Exclusion
- prior treatment with insulin glargine
- treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
1024 Patients enrolled
Trial Details
Trial ID
NCT00174824
Start Date
June 1 2001
End Date
April 1 2007
Last Update
March 27 2009
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada