Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes
Authors' conclusion
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.
Study context
- Population
- Patients with T1D diagnosed during the previous 100 days
- Participants
- 91 patients
- Comparison
- Baricitinib 4 mg once daily vs placebo, orally for 48 weeks
- Baricitinibn = 60
- Placebon = 31reference
- Primary endpoint
- Mean C-peptide level (AUC) during a 2-hour mixed-meal tolerance test
- Follow-up
- Week 48
Methodological detailsphase 2, double-blind, placebo-controlled
- Phase 2
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Mixed-meal-stimulated mean C-peptide level
P = 0.001
Secondary outcomes
| Outcome | Baricitinib | Placebo |
|---|---|---|
| Daily insulin dose · 48 weeks | mean 0.41 (95% CI 0.35–0.48) U per kilogram of body weight per day | mean 0.52 (95% CI 0.44–0.60) U per kilogram per day |
| Coefficient of variation of glucose (CGM) · 48 weeksMean | 29.6% (95% CI 27.8–31.3) | 33.8% (95% CI 31.5–36.2) |
HbA1c
- HbA1c levels were similar in the two groups
Safety
- Serious adverse events attributed to baricitinib or placebo
- 0
- Frequency and severity of adverse events similar in the two groups
Original publication
Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes. N Engl J Med. Published 7 December 2023. doi:10.
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