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Diabetic Neuropathies

Endpoints in Clinical Research Studies

  • Chapter
Controversies in Treating Diabetes

Part of the book series: Contemporary Endocrinology ((COE))

Summary

Clinical trials of agents for the treatment of diabetic neuropathy have been confronted with a lack of agreement on appropriate endpoints and have generated controversy on why ample demonstration of efficacy of an agent in animal studies has not been readily translated into success in human clinical trials. There has been a failure to recognize that the relief of symptoms does not equate to change in the underlying biological disorder and great disagreement on indices, which can reliably measure changes in nerve function which translate into changes in the quality of life, activities of daily living, and health of the individual. Here, one will focus on the various measures that have been used for the evaluation of symptoms and those that quantify nerve function and compare and contrast the reasons for failure of different measures neurological deficits, prevention of degeneration of specific small fiber, large fiber and autonomic nerve deficits and those that have potential for reversal of these deficits.

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Vinik, A.I. (2008). Diabetic Neuropathies. In: LeRoith, D., Vinik, A.I. (eds) Controversies in Treating Diabetes. Contemporary Endocrinology. Humana Press. https://doi.org/10.1007/978-1-59745-572-5_8

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