Evidence map›Paper›PMID 35606820›Full record

ArticleTrials2022

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

M Waibel, H E Thomas, J M Wentworth, J J Couper, R J MacIsaac, F J Cameron, M So, B Krishnamurthy, M C Doyle, T W Kay

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04774224 (A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04774224 phase2completednot on this map

A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus

TypeinterventionalSponsorSt Vincent's Institute of Medical ResearchRan2020 to 2024Enrolled91ConditionsType 1 DiabetesArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
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  5. Article
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  8. Article
  9. Article
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  11. Screening and Prevention of Type 1 Diabetes: Where Are We?The Journal of clinical endocrinology and metabolism · 2023
    Review
  12. Review
  13. Article
  14. Review
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

M Waibel *St Vincent's Institute of Medical Research, Melbourne, Australia.
H E Thomas *St Vincent's Institute of Medical Research, Melbourne, Australia.
J M Wentworth *Wentworth Department of Medical Biology, The University of Melbourne, Parkville, Victoria, 3010, Australia.
J J CouperRobinson Research Institute, University of Adelaide and Women's and Children's Hospital, Adelaide, Australia.
R J MacIsaacSt Vincent's Hospital, Melbourne, Australia.
F J CameronThe Royal Children's Hospital, Melbourne, Australia.
M SoSt Vincent's Institute of Medical Research, Melbourne, Australia.
B KrishnamurthySt Vincent's Institute of Medical Research, Melbourne, Australia.
M C DoyleSt Vincent's Institute of Medical Research, Melbourne, Australia.
T W KaySt Vincent's Institute of Medical Research, Melbourne, Australia. tkay@svi.edu.au.ORCID http://orcid.org/0000-0002-7273-2556
The University of Melbourne · AUSt Vincents Institute of Medical Research · AURoyal Children's Hospital · AUThe Royal Melbourne Hospital · AUWomen's and Children's Hospital · AU

Funding

Juvenile Diabetes Research Foundation Australia 4-SRA-2020-912-M-BJuvenile Diabetes Research Foundation United States of America 4-SRA-2020-912-M-B
6 · The paper itself

Abstract

backgroundType 1 diabetes (T1D) places an extraordinary burden on individuals and their families, as well as on the healthcare system. Despite recent advances in glucose sensors and insulin pump technology, only a minority of patients meet their glucose targets and face the risk of both acute and long-term complications, some of which are life-threatening. The JAK-STAT pathway is critical for the immune-mediated pancreatic beta cell destruction in T1D. Our pre-clinical data show that inhibitors of JAK1/JAK2 prevent diabetes and reverse newly diagnosed diabetes in the T1D non-obese diabetic mouse model. The goal of this study is to determine if the JAK1/JAK2 inhibitor baricitinib impairs type 1 diabetes autoimmunity and preserves beta cell function.

methodsThis will be as a multicentre, two-arm, double-blind, placebo-controlled randomized trial in individuals aged 10-30 years with recent-onset T1D. Eighty-three participants will be randomized in a 2:1 ratio within 100 days of diagnosis to receive either baricitinib 4mg/day or placebo for 48 weeks and then monitored for a further 48 weeks after stopping study drug. The primary outcome is the plasma C-peptide 2h area under the curve following ingestion of a mixed meal. Secondary outcomes include HbA1c, insulin dose, continuous glucose profile and adverse events. Mechanistic assessments will characterize general and diabetes-specific immune responses. DISCUSSION: This study will determine if baricitinib slows the progressive, immune-mediated loss of beta cell function that occurs after clinical presentation of T1D. Preservation of beta cell function would be expected to improve glucose control and prevent diabetes complications, and justify additional trials of baricitinib combined with other therapies and of its use in at-risk populations to prevent T1D.

trial registrationANZCTR ACTRN12620000239965 . Registered on 26 February 2020. CLINICALTRIALS: gov NCT04774224. Registered on 01 March 2021.

Indexed as

Diabetes Mellitus, Type 1AnimalsAzetidinesClinical Trials, Phase II as TopicC-PeptideDouble-Blind MethodGlucoseHumansJanus KinasesMiceMulticenter Studies as TopicPurinesPyrazolesRandomized Controlled Trials as TopicSignal TransductionSTAT Transcription FactorsAzetidinesbaricitinibC-PeptideGlucoseJanus KinasesPurinesPyrazolesSTAT Transcription FactorsSulfonamidesAutoimmune diseaseBaricitinibC-peptideInsulinJanus kinase (JAK) inhibitorRandomized controlled trial (RCT)Type 1 diabetes

Identifiers

PMID35606820
PMCPMC9125350
OpenAlexW4281290831

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.