A Look at Diabetes Mellitus and the Effects of a Study Drug on Diabetic Nephropathy




Schlueter, Cynthia K.


Journal Title

Journal ISSN

Volume Title



During my internship, I assisted with a twenty-four week, phase 2, double blinded, placebo controlled trial for a drug being developed to slow, if not prevent, the development of ESRD from overt neuropathy in patients with both type 1 and type 2 diabetes. This drug is a naturally occurring component of vitamin B6 and is an AGE-inhibitor. The AGE-inhibitory effect of the study drug was discovered by isolating Amadori products in the pathway to AGE formation. Once the intermediates were isolated, the sponsor’s scientists searched for compounds that could specifically block the conversion of these Amadori products into AGEs. The study drug was found to be a strong inhibitor of this pathway. In comparison, the common AGE inhibitor, aminoguanidine was found to be ineffective in blocking the post-Amadori foundation AGEs. Therefore, it must block AGE formation at one of the less clinically relevant pathways, and should be less effective in treating nephropathy according to the sponsor’s scientists. This study included type 1 and type 2 patients with clinically diagnosed diabetic retinopathy and a urinary albumin excretion rate (UAE) of greater than 300 mg/24h. Other inclusion and exclusion criteria were applied for the safety of the subjects and greater viability of the data.