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Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0\u20135.0\u00a0mmol\/l. Endpoints were assessed during a 36\u00a0week maintenance period and a total treatment period up to 88\u00a0weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [&lt;3.1\u00a0mmol\/l] with symptoms); (2) nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms, between 00:01 and 05:59\u00a0h); and (3) severe hypoglycaemia. The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions\/interpretation<\/jats:title>\n                <jats:p>There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> NCT03078478<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Funding<\/jats:title>\n                <jats:p>This trial was funded by Novo Nordisk (Bagsvaerd, Denmark)<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00125-019-05080-9","type":"journal-article","created":{"date-parts":[[2020,1,27]],"date-time":"2020-01-27T04:13:32Z","timestamp":1580098412000},"page":"698-710","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":68,"title":["Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial"],"prefix":"10.1007","volume":"63","author":[{"name":"on behalf of the CONCLUDE Study Group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3986-9630","authenticated-orcid":false,"given":"Athena","family":"Philis-Tsimikas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Klonoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamlesh","family":"Khunti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harpreet S.","family":"Bajaj","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence A.","family":"Leiter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa V.","family":"Hansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lone N.","family":"Troelsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steen","family":"Ladelund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Heller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas R.","family":"Pieber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,1,27]]},"reference":[{"issue":"2","key":"5080_CR1","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1002\/dmrr.796","volume":"24","author":"BM Frier","year":"2008","unstructured":"Frier BM (2008) How hypoglycaemia can affect the life of a person with diabetes. 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APT does not receive any direct or indirect payment for these services. DCK is a consultant for Abbott, Ascensia, EOFlow, Know, Lifecare, Merck, Novo Nordisk, Roche and Voluntis. KK has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche and Sanofi, and research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche and Sanofi, and also acknowledges support from the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care \u2013 East Midlands (NIHR CLAHRC \u2013 EM) and the National Institute of Health Research (NIHR) Leicester Biomedical Research Centre. HSB reports speaking honoraria or research support from Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk and Sanofi. LAL has received research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, GSK, Janssen, Novo Nordisk and Sanofi, and has been on advisory panels and provided continuing medical education for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi and Servier. MVH, LNT and SL are full-time employees of, and hold stock in, Novo Nordisk A\/S. SH has served on speaker panels for Eli Lilly and Novo Nordisk, for which he has received remuneration. He has served on advisory panels or as a consultant for Zeeland, UNEEG Medical, Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Sanofi Aventis and Takeda, for which his institution has received remuneration. TRP has received research support from Novo Nordisk and AstraZeneca (paid directly to the Medical University of Graz) and personal fees as a consultant from Adocia, Arecor, AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi. TRP is also the Chief Scientific Officer of CBmed (Center for Biomarker Research in Medicine), a public-funded biomarker research company.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Duality of interest"}}]}}