Sanofi-aventis Unveils Lantus Study Results

Published: 06-Jul-2009

The study showed long term safety of Lantus as compared to NPH

French pharmaceutical company Sanofi-aventis has unveiled 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 results showed similar effects on retinopathy and overall safety in the two treatment groups, said the company.

In the study of patients with retinopathy, the progression of diabetic retinopathy was similar in the two treatment groups over the long-term course of treatment. This indicates that Lantus does not have mitogenic effects different from the human NPH insulin within the eye.

The open-label study was specifically designed to characterize the retinal safety profile of Lantus versus NPH in 1024 patients (Lantus once daily: 515 patients and NPH twice daily: 509 patients).

Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center at Medical City, 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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