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Impact of treatment with saxagliptin on glycaemic stability and β‐cell function in the SAVOR‐TIMI 53 study
Author(s) -
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.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12445
Subject(s) - saxagliptin , medicine , placebo , dipeptidyl peptidase 4 inhibitor , type 2 diabetes , insulin , pharmacology , diabetes mellitus , endocrinology , gastroenterology , sitagliptin , metformin , alternative medicine , pathology
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 16 492 patients with type 2 diabetes ( T2D ) to saxagliptin or placebo, added to current antidiabetic medications, and followed them for a median of 2.1 years. Glycaemic instability was defined by: (i) a glycated haemoglobin ( HbA1c ) increase of ≥0.5% post‐randomization; (ii) the initiation of new antidiabetic medications for ≥3 months; or (iii) an increase in dose of oral antidiabetic medication or ≥25% increase in insulin dose for ≥3 months. 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 2 years, 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.