Retinopathy risk no greater with insulin glargine vs. NPH insulin

Diabetologia. 2009;doi:10.1007/s00125-009-1415-7.

Results of a 5-year study confirm that treatment with insulin glargine does not confer any greater risk for worsening retinopathy and overall safety in patients with type 2 diabetes compared with NPH insulin.

The open-label study examined the retinal safety profile of insulin glargine (Lantus, Sanofi-Aventis) vs. NPH insulin in 1,024 patients; 515 were assigned to once-daily insulin glargine and 509 to twice-daily NPH insulin.

Progression to retinopathy was evaluated using the Early Treatment Diabetic Retinopathy Study scale. At 5 years, scores were similar in both the insulin glargine (14.2%) and NPH insulin (15.7%) groups, despite a slightly greater severity of diabetic retinopathy in the insulin glargine-treated group at baseline.

"This 5-year study is the longest randomized, controlled study with insulin glargine vs. NPH human insulin," investigator Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City, said in a press release. "This study demonstrated no evidence of a greater risk of progression of retinopathy with insulin glargine."

Other measures of retinopathy, including development of proliferative diabetic retinopathy and progression to clinically significant macular edema, were also similar in both treatment groups.

The study was sponsored by Sanofi-Aventis.