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Efficacy and safety of dapagliflozin over 1 year as add‐on to insulin therapy in J apanese patients with type 2 diabetes: the DAISY (Dapagliflozin Added to patients under InSulin therapY) trial
Author(s) -
Araki Eiichi,
Onishi Yukiko,
Asano Michiko,
Kim Hyosung,
Yajima Toshitaka
Publication year - 2017
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.12853
Subject(s) - dapagliflozin , placebo , medicine , adverse effect , insulin , urinary system , type 2 diabetes , urology , diabetes mellitus , endocrinology , alternative medicine , pathology
Aims To evaluate the efficacy and safety of dapagliflozin as add‐on to insulin in J apanese patients with type 2 diabetes. Materials and methods Insulin‐treated J apanese patients were randomized to 5 mg dapagliflozin or placebo during a 16‐week double‐blind treatment period. Both groups then received dapagliflozin 5 or 10 mg (the dose was increased at or after week 24 if glycated haemoglobin [ HbA1c ] at the previous visit was >7.5%) during a 36‐week open‐label extension period. The exploratory efficacy endpoint was to assess the maintenance efficacy of 5/10 mg dapagliflozin + insulin over 52 weeks of treatment. Safety was assessed in terms of adverse events, laboratory variables and vital signs. Results The changes in HbA1c from baseline to weeks 16 and 52 were −0.62% and −0.74%, respectively, in the dapagliflozin group, vs −0.08% and −0.83%, respectively, in the placebo–dapagliflozin group. Body weight decreased at both time points in the dapagliflozin group and after switching to open‐label dapagliflozin in the placebo–dapagliflozin group. The total insulin dose decreased slightly after starting dapagliflozin. Adverse events occurred in 82.9% and 71.7% of patients in the dapagliflozin and placebo–dapagliflozin groups, respectively. Hypoglycaemia occurred in 35.0% and 41.7% of patients in the dapagliflozin and placebo–dapagliflozin groups, respectively, but the incidence was not increased by use of dapagliflozin in either trial period. Genital/urinary tract infections, renal impairment/failure, volume depletion, fracture and hepatic disorders occurred in ≤5% of patients. Conclusion This trial showed that administration of dapagliflozin as an add‐on to insulin therapy was effective, was well tolerated and had insulin‐sparing effects in J apanese patients with type 2 diabetes.