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Methods for Predicting Diabetes Phase III Efficacy Outcome From Early Data: Superior Performance Obtained Using Longitudinal Approaches
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. (Farmakometri)ORCID iD: 0000-0003-3531-9452
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2014 (English)In: CPT: pharmacometrics & systems pharmacology, ISSN 2163-8306, Vol. 3, no 7, e122- p.Article in journal (Refereed) Published
Abstract [en]

The link between glucose and HbA1c at steady state has previously been described using steady-state or longitudinal relationships. We evaluated five published methods for prediction of HbA1c after 26/28 weeks using data from four clinical trials. Methods (1) and (2): steady-state regression of HbA1c on fasting plasma glucose and mean plasma glucose, respectively, (3) an indirect response model of fasting plasma glucose effects on HbA1c, (4) model of glycosylation of red blood cells, and (5) coupled indirect response model for mean plasma glucose and HbA1c. Absolute mean prediction errors were 0.61, 0.38, 0.55, 0.37, and 0.15% points, respectively, for Methods 1 through 5. This indicates that predictions improved by using mean plasma glucose instead of fasting plasma glucose, by inclusion of longitudinal glucose data and further by inclusion of longitudinal HbA1c data until 12 weeks. For prediction of trial outcome, the longitudinal models based on mean plasma glucose (Methods 4 and 5) had substantially better performance compared with the other methods.

Place, publisher, year, edition, pages
2014. Vol. 3, no 7, e122- p.
National Category
Endocrinology and Diabetes
URN: urn:nbn:se:uu:diva-233721DOI: 10.1038/psp.2014.20PubMedID: 24988185OAI: oai:DiVA.org:uu-233721DiVA: diva2:753806
Available from: 2014-10-09 Created: 2014-10-09 Last updated: 2015-01-28Bibliographically approved

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Karlsson, Mats OKjellsson, M C
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