Impact of treatment with saxagliptin on glycaemic stability and β-cell function in the SAVOR-TIMI 53 study

G. Leibowitz, A. Cahn, D. L. Bhatt, B. Hirshberg, O. Mosenzon, C. Wei, G. Jermendy, W. H.H. Sheu, J. L. Sendon, K. Im, E. Braunwald, B. M. Scirica, I. Raz

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Abstract

Aims: To study the effects of saxagliptin, a dipeptidyl peptidase-4 inhibitor, on glycaemic stability and β-cell function in the SAVOR-TIMI 53 trial. Methods: We randomized 16492 patients with type 2 diabetes (T2D) to saxagliptin or placebo, added to current antidiabetic medications, and followed them for a median of 2.1years. Glycaemic instability was defined by: (i) a glycated haemoglobin (HbA1c) increase of ≥0.5% post-randomization; (ii) the initiation of new antidiabetic medications for ≥3months; or (iii) an increase in dose of oral antidiabetic medication or ≥25% increase in insulin dose for ≥3months. β-cell function was assessed according to fasting homeostatic model 2 assessment of β-cell function (HOMA-2β) values at baseline and at year 2 in patients not treated with insulin. Results: Compared with placebo, participants treated with saxagliptin had a reduction in the development of glycaemic instability (hazard ratio 0.71; 95% confidence interval 0.68-0.74; p<0.0001). In participants treated with saxagliptin compared with placebo, the occurrence of an HbA1c increase of ≥0.5% was reduced by 35.2%; initiation of insulin was decreased by 31.7% and the increases in doses of an oral antidiabetic drug or insulin were reduced by 19.5 and 23.5%, respectively (all p<0.0001). At 2years, HOMA-2β values decreased by 4.9% in participants treated with placebo, compared with an increase of 1.1% in those treated with saxagliptin (p<0.0001). Conclusions: Saxagliptin improved glycaemia and prevented the reduction in HOMA-2β values. Saxagliptin may reduce the usual decline in β-cell function in T2D, thereby slowing diabetes progression.

Original languageEnglish
Pages (from-to)487-494
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number5
DOIs
Publication statusPublished - May 1 2015

Keywords

  • Clinical trial
  • Dipeptidyl peptidase-4 inhibitor
  • Glycaemic control
  • Type 2 diabetes
  • β cell

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Leibowitz, G., Cahn, A., Bhatt, D. L., Hirshberg, B., Mosenzon, O., Wei, C., Jermendy, G., Sheu, W. H. H., Sendon, J. L., Im, K., Braunwald, E., Scirica, B. M., & Raz, I. (2015). Impact of treatment with saxagliptin on glycaemic stability and β-cell function in the SAVOR-TIMI 53 study. Diabetes, Obesity and Metabolism, 17(5), 487-494. https://doi.org/10.1111/dom.12445