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Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced diabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset diabetes following treatment with glucocorticoids (&gt;\u200920\u2009mg equivalent prednisolone dose\/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30\u2009days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrialsregister.eu\">www.clinicaltrialsregister.eu<\/jats:ext-link>no.:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2018-002640-82\/DK\">2018\u2013002640-82<\/jats:ext-link>. Prospectively registered November 20th. 2018.<\/jats:p><jats:p><jats:bold>Date of first patient enrolled:<\/jats:bold>June 4th. 2019.<\/jats:p><jats:p>This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12902-020-00561-0","type":"journal-article","created":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T12:02:55Z","timestamp":1592222575000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Study rationale and design of the EANITIATE study (EmpAgliflozin compared to NPH Insulin for sTeroId diAbeTEs) - a randomized, controlled, multicenter trial of safety and efficacy of treatment with empagliflozin compared with NPH-insulin in patients with newly onset diabetes following initiation of glucocorticoid treatment"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7702-8595","authenticated-orcid":false,"given":"Carina Kirstine","family":"Klarskov","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helga","family":"Holm Schultz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederik","family":"Persson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomas","family":"M\u00f8ller Christensen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas Peter","family":"Almdal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ole","family":"Snorgaard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katrine","family":"Bagge Hansen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulrik","family":"Pedersen-Bjergaard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Lommer Kristensen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,6,15]]},"reference":[{"issue":"3","key":"561_CR1","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1086\/431587","volume":"41","author":"LMAJ Muller","year":"2005","unstructured":"Muller LMAJ, Gorter KJ, Hak E, Goudzwaard WL, Schellevis FG, Hoepelman AIM, et al. 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All patients provide written informed consent before initiation of any study procedures. Patients can provide a separate consent for biobank sample collection. The study was approved by the Regional Committee on Biomedical Research and Ethics (H-18046227), the Danish Medicines Agency (2018091559) and the Danish Data Monitoring Board (VD-2018-250, I-suite 6491). The study is registered at(2018\u2013002640-82). The study is conducted in accordance with the Helsinki Declaration (2002) and the EU Directive on GCP and ICH-GCP guidelines. The study is monitored by the GCP-unit at Copenhagen University Hospital.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CKK: None. HHS: None. TMC: None. KBH: None. TPA reports ownership of shares in NovoNordisk A\/S. FP reports having received research grants from Astra Zeneca, lecture fees from Astra Zeneca, MSD, Janssen, Lily, Boehringer Ingelheim, Novo Nordisk, Novartis and being consultant\/advisory board member for Astra Zeneca, Bayer, Amgen and MSD. UPB has served on advisory boards for AstraZeneca, Bristol-Myers Squibb, Sanofi-Aventis, Novo Nordisk, and Zealand Pharma and has received lecture fees from AstraZeneca, Bristol-Myers Squibb, Sanofi-Aventis and Novo Nordisk. OS has been a speaker for Boehringer Ingelheim Danmark A\/S (2018), Sanofi Danmark and Novartis Healthcare A\/S. PLK has received lecture fees from Boehringer Ingelheim and Aztra Zeneca.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"86"}}