Baricitinib Shows Promise in Preserving β-Cell Function in Recent-Onset Type 1 Diabetes: A Phase 2 Clinical Trial

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In a groundbreaking phase 2 clinical trial, researchers conducted a double-blind, randomized, and placebo-controlled study to investigate the efficacy of baricitinib in preserving β-cell function in patients with type 1 diabetes diagnosed within the last 100 days. This 48-week trial focused on key parameters such as C-peptide levels, glycated hemoglobin, daily insulin dose, and glycemic control.

Methods

The trial enrolled a total of 91 patients, randomly assigned to either the baricitinib group (60 patients) or the placebo group (31 patients). Patients in the baricitinib group received a daily oral dose of 4 mg, while the placebo group received a matched placebo for the duration of the 48-week study.

Without the treatment, the immune cells attack and kill the insulin-producing cells. Credit: St Vincent’s Institute of Medical Research

Primary Outcome

The primary outcome measure 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. The results revealed a significant difference between the two groups. The median 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).

Secondary Outcomes

Secondary outcomes included the change from baseline in glycated hemoglobin levels, the daily insulin dose, and measures of glycemic control assessed using continuous glucose monitoring. At 48 weeks, the mean daily insulin dose in the baricitinib group was 0.41 U per kilogram of body weight per day (95% confidence interval [CI], 0.35 to 0.48), compared to 0.52 U per kilogram per day (95% CI, 0.44 to 0.60) in the placebo group.

Glycated hemoglobin levels were similar between 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 immune cells are disabled and are unable to kill the insulin-producing cell. Credit: St Vincent’s Institute of Medical Research

Safety and Adverse Events

The frequency and severity of adverse events were comparable in both trial groups, with no serious adverse events attributed to either baricitinib or placebo.

Conclusions

In conclusion, the findings suggest that daily treatment with baricitinib over 48 weeks in patients with recent-onset type 1 diabetes appears to preserve β-cell function, as evidenced by the mixed-meal–stimulated mean C-peptide level. This significant outcome paves the way for further research and potential therapeutic interventions in the management of type 1 diabetes. The study was funded by JDRF International and others, with the trial registered under the BANDIT Australian New Zealand Clinical Trials Registry number ACTRN12620000239965.


reference link : https://www.nejm.org/doi/10.1056/NEJMoa2306691

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