Baricitinib and β-cell function in patients with new-onset type 1 diabetes
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 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 i…
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Compared with teplizumab, some other immunotherapies not only preserve residual β-cell function, but also reduce insulin requirements and improve glycaemic control, without significant adverse events.
“Compared with teplizumab, some of these therapies not only preserve residual βcell function, but also reduce insulin requirements and improve glycaemic control, without significant adverse events (table 1).”
From The future of type 1 diabetes therapy (2025) · cites this paper as [23]
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- Authors
- Waibel, M., Wentworth, J. M., So, M., Couper, J. J., Cameron, F. J., MacIsaac, R. J., Atlas, G., Gorelik, A., Litwak, S., Sanz-Villanueva, L., Trivedi, P., Ahmed, S., Martin, F. J., Doyle, M. E., Harbison, J. E., Hall, C., Krishnamurthy, B., Colman, P. G., Harrison, L. C., Thomas, H. E., & Kay, T. W. H.
- Affiliations
- The University of Melbourne (AU)
- The Royal Melbourne Hospital (AU)
- Royal Children's Hospital (AU)
- 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.).
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2023-12-07
- Volume
- 389
- Issue
- 23
- Pages
- 2140-2150
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4389376234
- Cited by
- 194
- References
- 43
- Citations by year
- 2026: 52 · 2025: 76 · 2024: 63 · 2023: 3
- FWCI
- 32.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Funders
- National Health and Medical Research Council (GNT1150425)
- Juvenile Diabetes Research Foundation International (4-SRA-2020-912-M-B)
- Juvenile Diabetes Research Foundation Australia (4-SRA-2020-912-M-B)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- baricitinib, type 1 diabetes, recent-onset type 1 diabetes, beta-cell function, JAK inhibitors, C-peptide, mixed meal tolerance test, glycemic variability, insulin dose, HbA1c, continuous glucose monitoring, disease-modifying therapy, cytokine signaling inhibition, autoimmune disease therapy, adverse events, safety and tolerability, pharmacokinetics/pharmacodynamics
- MeSH terms
- Janus Kinase Inhibitors, Australia, Azetidines, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Double-Blind Method, Glycated Hemoglobin, Humans, Insulin, Purines, Pyrazoles, Sulfonamides, Blood Glucose Self-Monitoring, Insulin-Secreting Cells
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