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logo-32 logo-40 logo-60 Skip to main content New England Journal of Medicine * NEJM Group * Follow Us * Facebook. opens in new tab * Twitter. opens in new tab * Instagram. opens in new tab * YouTube. opens in new tab * LinkedIn. opens in new tab Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. . opens in new tab * NEJM Evidence NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. . opens in new tab * NEJM Catalyst NEW! 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Subscribe now. Already have an account? Sign in Original ArticleFree Preview BARICITINIB AND Β-CELL FUNCTION IN PATIENTS WITH NEW-ONSET TYPE 1 DIABETES List of authors. * Michaela Waibel, Ph.D., * John M. Wentworth, M.B., B.S., Ph.D., * Michelle So, M.B., B.S., Ph.D., * Jennifer J. Couper, M.D., * Fergus J. Cameron, M.D., * Richard J. MacIsaac, M.B., B.S., Ph.D., * Gabby Atlas, M.B., B.S., * Alexandra Gorelik, M.Sc., * Sara Litwak, Ph.D., * Laura Sanz-Villanueva, B.Sc., * Prerak Trivedi, Ph.D., * Simi Ahmed, Ph.D., * Francis J. Martin, Ph.D., * Madeleine E. Doyle, D.M., * Jessica E. Harbison, M.B., B.S., Ph.D., * Candice Hall, B.Sc., * Balasubramanian Krishnamurthy, M.D., * Peter G. Colman, M.D., * Leonard C. Harrison, M.D., D.Sc., * Helen E. Thomas, Ph.D., * and Thomas W.H. Kay, M.B., B.S., Ph.D. * et al., * for the BANDIT Study Group* A list of investigators in the BANDIT Study Group is provided in the Supplementary Appendix, available at NEJM.org. Drs. Waibel, Wentworth, and So and Profs. Thomas and Kay contributed equally to this article. December 7, 2023 N Engl J Med 2023; 389:2140-2150 DOI: 10.1056/NEJMoa2306691 * Related Articles ABSTRACT BACKGROUND Janus kinase (JAK) inhibitors, including baricitinib, block cytokine signaling and are effective disease-modifying treatments for several autoimmune diseases. Whether baricitinib preserves β-cell function in type 1 diabetes is unclear. METHODS Download a PDF of the Research Summary. In this phase 2, double-blind, randomized, placebo-controlled trial, we assigned patients with type 1 diabetes diagnosed during the previous 100 days to receive baricitinib (4 mg once per day) or matched placebo orally for 48 weeks. The primary outcome was the mean C-peptide level, determined from the area under the concentration–time curve, during a 2-hour mixed-meal tolerance test at week 48. Secondary outcomes included the change from baseline in the glycated hemoglobin level, the daily insulin dose, and measures of glycemic control assessed with the use of continuous glucose monitoring. RESULTS A total of 91 patients received baricitinib (60 patients) or placebo (31 patients). The median of the mixed-meal–stimulated mean C-peptide level at week 48 was 0.65 nmol per liter per minute (interquartile range, 0.31 to 0.82) in the baricitinib group and 0.43 nmol per liter per minute (interquartile range, 0.13 to 0.63) in the placebo group (P=0.001). The mean daily insulin dose at 48 weeks was 0.41 U per kilogram of body weight per day (95% confidence interval [CI], 0.35 to 0.48) in the baricitinib group and 0.52 U per kilogram per day (95% CI, 0.44 to 0.60) in the placebo group. The levels of glycated hemoglobin were similar in the two trial groups. However, the mean coefficient of variation of the glucose level at 48 weeks, as measured by continuous glucose monitoring, was 29.6% (95% CI, 27.8 to 31.3) in the baricitinib group and 33.8% (95% CI, 31.5 to 36.2) in the placebo group. The frequency and severity of adverse events were similar in the two trial groups, and no serious adverse events were attributed to baricitinib or placebo. CONCLUSIONS In patients with type 1 diabetes of recent onset, daily treatment with baricitinib over 48 weeks appeared to preserve β-cell function as estimated by the mixed-meal–stimulated mean C-peptide level. (Funded by JDRF International and others; BANDIT Australian New Zealand Clinical Trials Registry number, ACTRN12620000239965. opens in new tab.) QUICK TAKE VIDEO SUMMARY Baricitinib and β-Cell Function in New-Onset Type 1 Diabetes 02:13 CONTINUE READING THIS ARTICLE Select an option below: CREATE YOUR ACCOUNT TO GET 2 FREE SUBSCRIBER-ONLY ARTICLES EACH MONTH. Get Free Access Now Subscribe For Full Access ALREADY HAVE AN ACCOUNT? Sign In PRINT SUBSCRIBER? Activate your online access. Are you a member of an institution such as a university or hospital? Learn more about Institutional Access FUNDING AND DISCLOSURES Supported by JDRF International and JDRF Australia; a grant (4-SRA-2020-912-M-B) from the Australian Government Department of Health through the Emerging Priorities and Consumer-Driven Research Initiative, part of the Medical Research Future Fund; a grant (GNT1150425) from the National Health and Medical Research Council of Australia; and St. Vincent’s Institute of Medical Research, Australia. Philanthropic support was provided by the Romanes, Burgess, and Yencken families. Dr. So is supported by the Djinda Foundation Rising Star Fellowship. Infrastructure support has been provided to St. Vincent’s Institute by the Victorian State Government Operational Infrastructure Support Program. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Drs. Waibel, Wentworth, and So and Profs. Thomas and Kay contributed equally to this article. This is the New England Journal of Medicine version of record, which includes all Journal editing and enhancements. The Author Accepted Manuscript, which is the author’s version after external peer review and before publication in the Journal, is available at PubMed Central. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank the trial patients and their families; the study coordinators, nurses, and support staff at the trial sites; AK Clinical Research for trial monitoring; Resolutum Global for database set up and management; Tara Catterall, Evan Pappas, and Katherine Woods for logistic activities and processing related to mechanistic analyses and biobank samples; and Tom Brodnicki for administrative support. AUTHOR AFFILIATIONS From St. Vincent’s Institute of Medical Research (M.W., M.S., S.L., L.S.-V., P.T., M.E.D., C.H., B.K., H.E.T., T.W.H.K.), St. Vincent’s Hospital Melbourne (R.J.M., B.K., T.W.H.K.), and the Department of Medicine at St. Vincent’s Hospital, University of Melbourne (R.J.M., L.S.-V., M.E.D., B.K., H.E.T., T.W.H.K.), Fitzroy, the Walter and Eliza Hall Institute of Medical Research (J.M.W., P.G.C., L.C.H.), the Departments of Medical Biology (J.M.W., L.C.H.) and Medicine (A.G.), University of Melbourne, the Royal Melbourne Hospital (J.M.W., M.S., C.H., P.G.C., L.C.H.), the Royal Children’s Hospital (F.J.C., G.A.), and the Murdoch Children’s Research Institute (F.J.C.), Parkville, and the School of Public Health and Preventive Medicine, Monash University, Melbourne (A.G.), VIC, and Women’s and Children’s Hospital (J.J.C., J.E.H.) and the University of Adelaide (J.J.C.), Adelaide, SA — all in Australia; the New York Stem Cell Foundation, New York (S.A.); and Macromoltek, Austin, TX (F.J.M.). Prof. Kay can be contacted at tkay@svi.edu.au or at St. Vincent’s Institute of Medical Research, 9 Princes St., Fitzroy VIC 3065, Australia. A list of investigators in the BANDIT Study Group is provided in the Supplementary Appendix, available at NEJM.org. * Share * Facebook. opens in new tab * Twitter. opens in new tab * LinkedIn. opens in new tab * Email * Copy URL * * * More * Permissions December 7, 2023 N Engl J Med 2023; 389:2140-2150 DOI: 10.1056/NEJMoa2306691 Print Subscriber? Activate your online access. Related Articles * EditorialDec 7, 2023 Immune Interventions at Onset of Type 1 Diabetes — Finally, a Bit of Hope J. Ludvigsson * Original ArticleDec 7, 2023 Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes E.L. 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