{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:59:05Z","timestamp":1777420745813,"version":"3.51.4"},"reference-count":54,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2019,6,21]],"date-time":"2019-06-21T00:00:00Z","timestamp":1561075200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:p>\n                    Objective: To review phase 3 trials of sodium-glucose cotransporter (SGLT) inhibitors in type 1 diabetes mellitus (T1DM) patients. Data Sources: A literature search of Ovid MEDLINE databases (1946 through May 17, 2019) limited to English-language human clinical trials was conducted using the following terms: sodium-glucose transporter 2 inhibitors, canagliflozin, dapagliflozin, empagliflozin, sotagliflozin, ertugliflozin, ipragliflozin, or remogliflozin combined with type 1 diabetes mellitus. Results were verified via Google Scholar and clinicaltrials.gov. Study Selection and Data Extraction: Articles were included if they were phase 3 trials in adults with T1DM. Data Synthesis: Phase 3 trials are available for dapagliflozin, empagliflozin, and sotagliflozin. All 3 drugs demonstrated statistically significant reductions in hemoglobin A\n                    <jats:sub>1C<\/jats:sub>\n                    , weight, and total daily insulin dose without an increased risk of hypoglycemia in up to 52 weeks of therapy. The incidence of diabetic ketoacidosis (DKA) was higher in patients on a SGLT inhibitor at all doses, with the exception of empagliflozin 2.5 mg (0.8% vs 1.2% with placebo). Relevance to Patient Care and Clinical Practice: SGLT inhibitors are potential adjuncts to insulin in T1DM patients, providing clinically meaningful benefits. Regulatory bodies have either approved or are reviewing these agents for use in T1DM. Clinicians should be familiar with the DKA risk associated with SGLT inhibitors and utilize DKA risk-mitigation strategies. Empagliflozin 2.5 mg warrants additional investigation given its efficacy without an increased incidence of DKA. Conclusions: Phase 3 trial data of SGLT inhibitors provide evidence for sustained efficacy in T1DM patients. Appropriate patient selection for therapy and routine monitoring are essential to minimize associated risks.\n                  <\/jats:p>","DOI":"10.1177\/1060028019859323","type":"journal-article","created":{"date-parts":[[2019,6,22]],"date-time":"2019-06-22T02:05:10Z","timestamp":1561169110000},"page":"1227-1237","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Sodium-Glucose Cotransporters as Potential Therapeutic Targets in Patients With Type 1 Diabetes Mellitus: An Update on Phase 3 Clinical Trial Data"],"prefix":"10.1177","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4016-4600","authenticated-orcid":false,"given":"Kajal","family":"Patel","sequence":"first","affiliation":[{"name":"Fairleigh Dickinson University School of Pharmacy and Health Sciences, Florham Park, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonia","family":"Carbone","sequence":"additional","affiliation":[{"name":"Fairleigh Dickinson University School of Pharmacy and Health Sciences, Florham Park, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2019,6,21]]},"reference":[{"key":"bibr1-1060028019859323","unstructured":"Centers for Disease Control and Prevention. National diabetes statistics report, 2017: estimates of diabetes and its burden in the United States. https:\/\/www.cdc.gov\/diabetes\/pdfs\/data\/statistics\/national-diabetes-statistics-report.pdf. Accessed April 1, 2019."},{"key":"bibr2-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-S009"},{"key":"bibr3-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052187"},{"key":"bibr4-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401"},{"key":"bibr5-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-2723"},{"key":"bibr6-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2006.00686.x"},{"key":"bibr7-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13941"},{"key":"bibr8-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmet.2017.04.011"},{"key":"bibr9-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00055.2009"},{"key":"bibr10-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1097\/MNH.0000000000000152"},{"key":"bibr11-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-med-051013-110046"},{"key":"bibr12-1060028019859323","unstructured":"Invokana [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; 2018."},{"key":"bibr13-1060028019859323","unstructured":"Farxiga [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018."},{"key":"bibr14-1060028019859323","unstructured":"Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc; 2018."},{"key":"bibr15-1060028019859323","unstructured":"Steglatro [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohma Corp Inc; 2018."},{"key":"bibr16-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01569.x"},{"key":"bibr17-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2147\/DMSO.S76342"},{"key":"bibr18-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.114.214304"},{"key":"bibr19-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.113.203364"},{"key":"bibr20-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1177\/1060028017710481"},{"key":"bibr21-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1730"},{"key":"bibr22-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2955"},{"key":"bibr23-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12494"},{"key":"bibr24-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-2806"},{"key":"bibr25-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12882"},{"key":"bibr26-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(17)30308-X"},{"key":"bibr27-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1087"},{"key":"bibr28-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-0623"},{"key":"bibr29-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1983"},{"key":"bibr30-1060028019859323","unstructured":"AstraZeneca. Forxiga approved in Europe for type-1 diabetes. https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2019\/forxiga-approved-in-europe-for-type-1-diabetes22032019.html. Published March 25, 2019. Accessed April 9, 2019."},{"key":"bibr31-1060028019859323","unstructured":"AstraZeneca. Forxiga approved in Japan for type-1 diabetes. https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2019\/forxiga-approved-in-japan-for-type-1-diabetes-27032019.html. Published March 27, 2019. Accessed April 15, 2019."},{"key":"bibr32-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0141085"},{"key":"bibr33-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2840-13-28"},{"key":"bibr34-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2338"},{"key":"bibr35-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.005081"},{"key":"bibr36-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1186\/s12933-018-0797-6"},{"key":"bibr37-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1749"},{"key":"bibr38-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13351"},{"key":"bibr39-1060028019859323","unstructured":"Boehringer Ingelheim. Boehringer Ingelheim and Lilly present full results from EASE Phase III programme for empagliflozin as adjunct to insulin in type 1 diabetes. https:\/\/www.boehringer-ingelheim.us\/press-release\/boehringer-ingelheim-and-lilly-present-full-results-ease-phase-iii. Accessed June 8, 2019."},{"key":"bibr40-1060028019859323","unstructured":"Lexicon Pharmaceuticals. FDA Advisory Committee votes on Zynquista\u2122 (sotagliflozin) as treatment for adults with type 1 diabetes. http:\/\/www.lexpharma.com\/media-center\/news\/696-fda-advisory-committee-votes-on-zynquistatm-sotagliflozin-as-treatment-for-adults-with-type-1-diabetes. Published January 17, 2019. 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Published April 26, 2019. Accessed May 22, 2019."},{"key":"bibr47-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.028268"},{"key":"bibr48-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"bibr49-1060028019859323","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13077"},{"key":"bibr50-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-9032"},{"key":"bibr51-1060028019859323","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1380"},{"key":"bibr52-1060028019859323","unstructured":"US 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. https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm475463.htm. 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