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Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes.
Michaela Waibel1, John M Wentworth1, Michelle So1
1From 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.).
Baricitinib, a Janus kinase (JAK) inhibitor, demonstrated potential in preserving pancreatic beta-cell function in recent-onset type 1 diabetes patients over 48 weeks. This study suggests baricitinib may be a valuable therapeutic option for type 1 diabetes management.
Area of Science:
- Immunology
- Endocrinology
- Clinical Trials
Background:
- Janus kinase (JAK) inhibitors like baricitinib are used for autoimmune diseases by blocking cytokine signaling.
- The efficacy of baricitinib in preserving beta-cell function in type 1 diabetes (T1D) remains uncertain.
Purpose of the Study:
- To evaluate the effect of baricitinib on beta-cell function in patients with recent-onset type 1 diabetes.
- To assess secondary outcomes including glycemic control and insulin requirements.
Main Methods:
- Phase 2, double-blind, randomized, placebo-controlled trial involving 91 patients with T1D diagnosed within 100 days.
- Patients received either 4 mg of baricitinib or placebo daily for 48 weeks.
- Primary outcome: mean C-peptide level from a mixed-meal tolerance test at 48 weeks; secondary outcomes: HbA1c, insulin dose, and continuous glucose monitoring (CGM) data.
Main Results:
- Baricitinib group showed a significantly higher median C-peptide level (0.65 nmol/L/min) compared to placebo (0.43 nmol/L/min) at 48 weeks (P=0.001).
- Mean daily insulin dose was lower in the baricitinib group (0.41 U/kg/day) versus placebo (0.52 U/kg/day).
- Glycated hemoglobin levels were similar; however, baricitinib group exhibited improved glycemic control (lower coefficient of variation on CGM). Adverse events were comparable between groups.
Conclusions:
- Daily baricitinib treatment for 48 weeks appears to preserve beta-cell function in patients with recent-onset type 1 diabetes, as indicated by C-peptide levels.
- Baricitinib may help reduce insulin requirements and improve glycemic variability in T1D.
- The study supports baricitinib as a potential disease-modifying therapy for early-stage type 1 diabetes.
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