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Sanofi-aventis Provides Results For Lantus Study

PBR Staff Writer Published 06 July 2009

To characterize the retinal safety profile of insulin glargine and human neutral protamine Hagedorn insulin, in patients with type 2 diabetes

Sanofi-aventis has published the results of the five-year study of Lantus (insulin glargine injection) versus NPH insulin, on progression of retinopathy in patients with type 2 diabetes.

The data showed similar effects on retinopathy and overall safety in the two treatment groups.

The open-label study was specifically designed to further characterize the retinal safety profile of Lantus versus NPH in 1024 patients. Progression was evaluated using the Early Treatment Diabetic Retinopathy Study. The scores at study end were similar in both treatment groups, said the company.

Julio Rosenstock, Lead Investigator, Director of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine, University of Texas, said: This 5-year study is the longest randomized controlled study with insulin glargine versus NPH human insulin. This study demonstrated no evidence of a greater risk of progression of retinopathy with insulin glargine.

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