{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T05:38:19Z","timestamp":1790746699109,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,10,26]],"date-time":"2017-10-26T00:00:00Z","timestamp":1508976000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the safety and tolerability of dapagliflozin, a highly selective sodium\u2010glucose co\u2010transporter\u20102 inhibitor, in patients with type 2 diabetes mellitus (T2DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were pooled from 13 placebo\u2010controlled trials of up to 24\u2009weeks\u2019 duration (dapagliflozin, n\u2009=\u20092360; placebo, n\u2009=\u20092295). Larger placebo\u2010\/comparator\u2010controlled pools of 21 (\u2264208\u2009weeks; dapagliflozin, n\u2009=\u20095936; control, n\u2009=\u20093403) and 30 trials (\u226512\u2009weeks; dapagliflozin, n\u2009=\u20099195; control, n\u2009=\u20094629) assessed the rare adverse events (AEs) of diabetic ketoacidosis (DKA) and lower limb amputation, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Over 24\u2009weeks, the overall incidence of AEs and serious AEs (SAEs) was similar for dapagliflozin and placebo: 60.0% vs 55.7% and 5.1% vs 5.4%, respectively. Rates of hypoglycaemia, volume depletion AEs, urinary tract infections (UTIs) and fractures were balanced between the groups. Genital infections were more frequent with dapagliflozin (5.5%) vs placebo (0.6%) and renal function AEs occurred in 3.2% vs 1.8% of patients (the most common renal AE was decreased creatinine clearance: 1.1% vs 0.7%). In the 21\u2010study pool, 1 SAE of DKA and 3 AEs of ketonuria\/metabolic acidosis occurred with dapagliflozin vs none with control; estimated combined incidence for these events was 0.03% (95% confidence interval 0.010\u20100.089). In the 30\u2010study pool, lower limb amputation occurred in 8 (0.1%) and 7 (0.2%) patients receiving dapagliflozin and control, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The overall incidence rates of AEs and SAEs were similar in the dapagliflozin and placebo\/control groups, including the incidence of hypoglycaemia, volume depletion, fractures, UTIs, amputations and DKA. Genital infections were more frequent with dapagliflozin than placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13124","type":"journal-article","created":{"date-parts":[[2017,9,26]],"date-time":"2017-09-26T11:37:41Z","timestamp":1506425861000},"page":"620-628","source":"Crossref","is-referenced-by-count":132,"title":["Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb\/III clinical trials"],"prefix":"10.1111","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4080-0470","authenticated-orcid":false,"given":"Serge","family":"Jabbour","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Sidney Kimmel Medical College at Thomas Jefferson University  Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Seufert","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Diabetology, Department of Internal Medicine II University Hospital of Freiburg, Medical Faculty, University of Freiburg  Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9743-4371","authenticated-orcid":false,"given":"Andre","family":"Scheen","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Li\u00e8ge  Li\u00e8ge Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clifford J.","family":"Bailey","sequence":"additional","affiliation":[{"name":"School of Life and Health Sciences, Aston University  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathrina","family":"Karup","sequence":"additional","affiliation":[{"name":"Department of AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA), AstraZeneca Gothenburg  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna M.","family":"Langkilde","sequence":"additional","affiliation":[{"name":"Department of R&amp;D AstraZeneca Gothenburg  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,10,26]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504720"},{"key":"e_1_2_6_4_1","first-page":"451","article-title":"Sodium\u2010glucose linked transporter 2 (SGLT2) inhibitors in the management of Type\u20102 diabetes: a drug class overview","volume":"40","author":"Mosley JF","year":"2015","journal-title":"P T"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.250"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0337-y"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11892-016-0789-4"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/dme.12624"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-11-43"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12327"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12187"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-0467"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2016.03.031"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-017-0573-0"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2016.1271780"},{"key":"e_1_2_6_16_1","unstructured":"Food and Drug Administration. FDA drug safety communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections.2015.https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm475463.htm. Accessed December 4 2016."},{"key":"e_1_2_6_17_1","unstructured":"Food and Drug Administration. FDA drug safety communication: FDA revises label of diabetes drug canagliflozin (Invokana Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density.2015.http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm461449.htm. Accessed October 11 2017."},{"key":"e_1_2_6_18_1","unstructured":"Food and Drug Administration. FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin.2017.https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm557507.htm. Accessed May 16 2017."},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-3167"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0213-4"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpregu.00357.2011"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/MNH.0b013e3283331ffd"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.005081"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40620-016-0261-1"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1515920"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2015.1092128"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1080\/00325481.2016.1153941"},{"key":"e_1_2_6_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-015-0117-z"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12670"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.080486"},{"key":"e_1_2_6_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(14)70227-X"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01630.x"},{"key":"e_1_2_6_33_1","unstructured":"European Medicines Agency. Summary of product characteristics: Canagliflozin.2013."},{"key":"e_1_2_6_34_1","doi-asserted-by":"publisher","DOI":"10.1093\/omcr\/omw061"},{"key":"e_1_2_6_35_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP161292.PS"},{"key":"e_1_2_6_36_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1995"},{"key":"e_1_2_6_37_1","unstructured":"US Food and Drug Administration. Dapagliflozin. Background document.2011.https:\/\/wayback.archive\u2010it.org\/7993\/20170405220514\/https:\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/EndocrinologicandMetabolicDrugsAdvisoryCommittee\/UCM262996.pdf. Accessed October 11 2017."},{"key":"e_1_2_6_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-015-0128-9"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.13124","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.13124","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T05:40:51Z","timestamp":1761889251000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.13124"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,10,26]]},"references-count":37,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2018,3]]}},"alternative-id":["10.1111\/dom.13124"],"URL":"https:\/\/doi.org\/10.1111\/dom.13124","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,10,26]]}}}