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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• prior treatment with insulin glargine

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