Investigating the efficacy of baricitinib in new onset type 1 diabetes mellitus (BANDIT)—study protocol for a phase 2, randomized, placebo-controlled trial.

Published Date:

December 7, 2023.

Published By:

Waibel, H. E. Thomas,J. M. Wentworth,. J. Couper,5 R. J. MacIsaac, F. J. Cameron,8 M. So, B. Krishnamurthy, M. C. Doyle, and T. W. Kay corresponding author.

Approved By:
To be

Decoded By:
Asra H. Ahmed MBA, PGCE in Assessment Learning disability, Diabesties Foundation

10 mins to read

  • The T1D Takeaway
  • A Reversal of T1D. Wait…What?!? There is potential of hope that persons newly diagnosed with type 1 diabetes can with, daily treatment with baricitinib over period save beta-cell function. This may further lead to reversal of type 1 diagnosis.

Word Wizard

Autoimmune Disease
Baricitinib
C-peptide
Cytokine
Immune-mediated
Janus kinase (JAK) inhibitor
Monoclonal antibodies
Randomized controlled trial (RCT)
Type 1 diabetes
  • Type 1 diabetes (T1D) is challenging for individuals, and the healthcare system.
  • Despite improved technology, many T1D patients struggle to control blood sugar, facing immediate and long-term risks.
  • A randomized, controlled trial of 91 individuals newly diagnosed with Type 1 Diabetes were included in the JAK-STAT pathway is crucial for the immune attack on insulin-producing cells in T1D.
  • Research indicates that JAK1/JAK2 inhibitors can prevent and reverse diabetes in mice.
  • The study’s goal is to see if the JAK1/JAK2 inhibitor baricitinib can reduce T1D-related immune issues and protect beta cell function. randomized, controlled trial of 91 patients.

Summary Snap
Shots

This research aims to find out if a medicine called baricitinib can help lower the immune problems in type 1 diabetes and keep the beta cells working and produce insulin from within.

Prime Insight

The aim of this study is to assess whether the JAK inhibitor baricitinib can slow the progressive, immune-mediated loss of beta cell mass and function that occurs after clinical presentation. This will be measured via plasma C-peptide, a surrogate marker of insulin secretion.

Janus Kinase Pathway is a way of using medication that interferes with using enzymes involved in signaling between cells to change autoimmune response within the body that can lead to beta cell destruction. When these molecules bind, Janus kinases (JAKs) activate the receptors.

In a JDRF-funded clinical trial, published in the renowned New England Journal of Medicine, Thomas Kay, M.B.B.S., Helen Thomas, Ph.D., and others demonstrated that baricitinib—a JAK inhibitor, which is critical to signaling pathways within both immune cells and beta cells in type 1 diabetes (T1D)—preserved beta cell function in the disease. Further, this medication has been previously approved by FDA for other autoimmune conditions.

The study is the first to test if JAK inhibitors can slow down Type 1 Diabetes (T1D) in both children and adults. It aims to understand how these inhibitors impact T1D progression. The research will provide insights into the effects of baricitinib in cells producing insulin.

Activated receptors then bind to cellular response proteins, regulating gene. A process by which information in a gene is used to synthesize a protein. In autoimmune diseases, JAK-STAT and interferon signaling are crucial pathways. Blocking or removing individual signaling molecules/receptors has limited impact compared to manipulating the entire signaling pathway.

C-peptide levels over 2 hours after a meal test at 48 weeks was measured. Changes in C-peptide levels, daily insulin use, HbA1c levels were evaluated. Glucose levels, using a CGM were recorded and potential side effects were noted.

The study suggests that baricitinib may help preserve beta-cell function in recent-onset type 1 diabetes.

  • A Deeper Dive
  • The Sources Voice

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.

  • Curiosities Clarified

Baricitinib is a Janus kinase (JAK) inhibitor that is primarily used in the treatment of rheumatoid arthritis and other autoimmune conditions. The conclusions of the above study has shown very prosimising results among those who were treated in early stages of Type 1 diabetes.

The trial showed significant preservation of Beta cells. That’s super exciting for people living with type 1 diabetes as cure is still being researched at least their own Beta cells may be preserved for longer.

Baricitinib realistically speaking is not a cure, but it surely can preserve Beta cells and delay the onset of diabetes. The production of insulin is very promising.

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