Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00174824

Run by

Sanofi

People needed

1024

Starts

2001-06-01

Expected to finish

2007-04-01

Last updated by the study team

2009-03-27

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• prior treatment with insulin glargine
• treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Laval, Canada

Full record on ClinicalTrials.gov

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