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Efficacy and safety of triple therapy with dapagliflozin add‐on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes
Author(s) -
Mathieu C.,
Herrera Marmolejo M.,
González González J. G.,
Hansen L.,
Chen H.,
Johnsson E.,
GarciaSanchez R.,
Iqbal N.
Publication year - 2016
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.12737
Subject(s) - dapagliflozin , saxagliptin , metformin , medicine , placebo , type 2 diabetes , adverse effect , diabetes mellitus , urology , endocrinology , sitagliptin , alternative medicine , pathology
We previously reported that dapagliflozin versus placebo as add‐on to saxagliptin plus metformin resulted in greater reductions in glycated haemoglobin ( A1C ), fasting plasma glucose ( FPG ) and body weight ( BW ) after 24 weeks of treatment in patients with type 2 diabetes ( T2D ). Here we report results after 52 weeks of treatment. Patients stabilized on open‐label metformin and saxagliptin 5 mg/day for 8‐16 weeks were randomized to placebo or dapagliflozin 10 mg/day plus open‐label saxagliptin plus metformin for 52 weeks. Changes from baseline to week 52 were greater with dapagliflozin versus placebo in A1C (−0.74% vs. 0.07%), FPG (−27 vs. 10 mg/ dL ) and BW (−2.1 vs. −0.4 kg). More patients achieved A1C <7% with dapagliflozin (29.4%) versus placebo (12.6%). Adverse events were similar with dapagliflozin (66%) and placebo (71%), and hypoglycaemia was rare (≤2%). Genital infections occurred more often with dapagliflozin (6%) than with placebo (1%); frequency of urinary tract infections was similar between the two groups (9% vs. 10%). Triple therapy with dapagliflozin add‐on to saxagliptin plus metformin is a durable, effective and well‐tolerated intervention for the treatment of T2D .