AI Article Synopsis
- Tregopil is a new PEGylated human insulin being developed for oral delivery in diabetes treatment, focused on creating a specific method to measure its levels in patients taking Glargine.
- A sensitive electrochemiluminescent ELISA method was successfully created, capable of quantifying Tregopil in serum with a low limit of detection.
- This method demonstrates minimal cross-reactivity with Glargine, making it a reliable tool for accurately measuring Tregopil in Type 1 diabetes patients during clinical studies.
Article Abstract
Aim: Tregopil, a novel PEGylated human insulin is in clinical development for oral delivery in diabetes treatment. The aim of the study was to develop and validate a sensitive and specific ELISA method for quantitating Tregopil in diabetes subjects on basal Glargine, since most commercially available insulin kits either do not detect Tregopil or show significant reactivity to Glargine.
Methods: An electrochemiluminescent ELISA was developed and validated for Tregopil quantitation in diabetes serum.
Results: The method has a LLOQ of 0.25 ng/ml, shows minimum cross-reactivity to Glargine and was successfully tested using a subset of samples from Tregopil-dosed Type 1 diabetes mellitus patients.
Conclusion: The ELISA method is sensitive and can be used to support accurate measurement of Tregopil with no cross-reactivity to Glargine and its metabolites in clinical studies.
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Source |
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| http://dx.doi.org/10.4155/bio-2017-0020 | DOI Listing |
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