Evidence map›Paper›PMID 42608595›Full record

Trial reportDiabetologia2026

A multi-centre study of belatacept and sirolimus for islet transplantation.

Natasha M Rogers, Min Hu, Elvira Jimenez-Vera, Hugh Gabor, Preeti P Sharma, Colleen Etherton, Tom Loudovaris, Wayne J Hawthorne, Chris J Drogemuller, David J Torpy and 8 more

Abstract readMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Natasha M RogersNational Pancreas Transplant Unit, Westmead Hospital, Westmead, NSW, Australia. natasha.rogers@health.nsw.gov.au.ORCID http://orcid.org/0000-0003-2456-9544
Min HuCentre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead, NSW, Australia.ORCID http://orcid.org/0000-0003-3750-220X
Elvira Jimenez-VeraCentre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead, NSW, Australia.
Hugh GaborCentre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead, NSW, Australia.
Preeti P SharmaCentre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead, NSW, Australia.ORCID http://orcid.org/0000-0001-8969-0076
Colleen EthertonCentral Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, SA, Australia.
Tom LoudovarisImmunology and Diabetes Unit, St Vincent's Institute of Medical Research, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-7038-2302
Wayne J HawthorneCentre for Transplant and Renal Research, Westmead Institute for Medical Research, Westmead, NSW, Australia.ORCID http://orcid.org/0000-0001-8638-3468
Chris J DrogemullerCentral Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, SA, Australia.ORCID http://orcid.org/0000-0001-9770-4845
David J TorpyEndocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.ORCID http://orcid.org/0000-0002-5069-0981
Deborah J Holmes-WalkerFaculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.ORCID http://orcid.org/0000-0002-3640-1370
Brian GlossWestmead Bioinformatics Facility, Westmead Institute for Medical Research, Westmead, NSW, Australia.ORCID http://orcid.org/0000-0001-7695-4394
Shane T GreySchool of Biotechnology and Biomolecular Sciences, Faculty of Science, The University of New South Wales, Sydney, NSW, Australia.ORCID http://orcid.org/0000-0003-2160-1625
David GoodmanDepartment of Nephrology, St Vincent's Hospital Melbourne, Fitzroy, VIC, Australia.ORCID http://orcid.org/0000-0002-6776-481X
P Toby CoatesCentral Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, SA, Australia.ORCID http://orcid.org/0000-0003-0342-8179
Tom W KayImmunology and Diabetes Unit, St Vincent's Institute of Medical Research, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-7273-2556
Philip J O'ConnellNational Pancreas Transplant Unit, Westmead Hospital, Westmead, NSW, Australia. philip.oconnell@sydney.edu.au.ORCID http://orcid.org/0000-0002-2036-283X
Australian Islet Consortium

Funding

Juvenile Diabetes Research Foundation International GNT 201302657
6 · The paper itself

Abstract

aims/hypothesisIslet transplantation is an appropriate treatment for selected individuals with type 1 diabetes mellitus and hypoglycaemia unawareness. The gold standard of maintenance immunosuppression to prevent allograft rejection is calcineurin inhibitor-based therapy; however, side effects warrant exploration of alternative immunosuppression. The co-stimulatory blocker belatacept and the mammalian target of rapamycin inhibitor sirolimus have demonstrated clinical benefit in solid organ transplantation, but efficacy in human islet transplantation is unknown.

methodsWe conducted a non-randomised, phase 2, multi-centre, open-label clinical study. Participants with type 1 diabetes receiving at least one islet transplant were treated with belatacept/sirolimus (bela/siro) and compared with a contemporaneous cohort treated with tacrolimus/mycophenolate mofetil (tac/MMF). The primary outcome was freedom from hypoglycaemia, with positive C-peptide and HbA

resultsNine participants with type 1 diabetes received bela/siro, compared with 24 receiving tac/MMF. Eight participants (89%) receiving bela/siro achieved the primary outcome compared with 12 (52%) from the tac/MMF cohort. HbA CONCLUSIONS/

interpretationBaseline immunosuppression with bela/siro facilitated early islet engraftment and rates of insulin independence, with less impact on renal function, supporting the rationale for routine use in islet transplantation.

trial registrationANZCTR.org.au ACTRN12619000268145.

Indexed as

AbataceptDiabetes Mellitus, Type 1Immunosuppressive AgentsIslets of Langerhans TransplantationSirolimusAdultC-PeptideFemaleGlycated HemoglobinHumansMaleMiddle AgedMycophenolic AcidTacrolimusAbataceptC-PeptideGlycated HemoglobinImmunosuppressive AgentsMycophenolic AcidSirolimusTacrolimusBelataceptCalcineurin inhibitorImmunosuppressionIslet transplantationNephropathyRegulatory T cellsSirolimusType 1 diabetes

Identifiers

PMID42608595
PMCPMC13541912

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.