, Volume 52, Issue 9, pp 1971-1973,
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Date: 16 Jul 2009

Similar risk of malignancy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: findings from a 5 year randomised, open-label study

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To the Editor: We have reported a randomised, long-term safety study comparing the effects of using the insulin analogue glargine (A21Gly,B31Arg,B32Arg human insulin) versus human neutral protamine Hagedorn (NPH) insulin for 5 years in the management of type 2 diabetes [1]. The study, in which 1017 patients were randomised and treated, was designed to assess ocular complications of diabetes: there was no excess of such effects with insulin glargine compared with NPH insulin treatment and there was a similar slow progression of diabetic retinopathy with both types of insulin. Because of recent concerns about postulated neoplastic effects of insulins [25], we report here additional information from our study that bears on this question.

In total, the mean cumulative exposure in our study was more than 4 years (1,524 days in the insulin glargine group and 1,522 days in the NPH insulin group), with more than 70% of patients exposed to more than 4 years of treatment (76% and 71%, respective ...