Recruiting NCT07222137
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baricitinib, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 1 year — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Brazil, Canada +13
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
Overview
The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
Interventions
- Drug Baricitinib
Administered orally - Drug Placebo
Administered orally
Primary outcome measures
- Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [Time frame: Baseline up to approximately 5 years]
Secondary outcome measures (10)
- Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC) [Time frame: Baseline, Week 52]
- Change from Baseline in Glucose AUC [Time frame: Baseline, Week 52]
- Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000) [Time frame: Baseline, Week 52]
- Change from Baseline in Height [Time frame: Baseline, Week 52]
- Change from Baseline in Body Mass Index (BMI) Percentile [Time frame: Baseline, Week 52]
- Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive) [Time frame: Baseline, Week 52]
- Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2) [Time frame: Baseline, Week 52]
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [Time frame: Predose through Week 24]
- PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib [Time frame: Predose through Week 24]
- Change from Baseline in Matsuda Index [Time frame: Baseline, Week 52]
Eligibility criteria
Inclusion criteria
- Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening
- Have Stage 1b or Stage 2 type 1 diabetes
- Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening
Exclusion criteria
- Have any other type of diabetes
- Have uncontrolled high blood pressure
- Have had a heart attack, heart disease, stroke, or heart failure
- Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
- Have a current or recent clinically serious infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Israel · 13 centers
- Yitzhak Shamir Medical Center — Beer Yaacov
- Soroka Medical Center — Beersheba
- Rambam Health Care Campus — Haifa
- Carmel Hospital — Haifa
- Institute of Diabetes, Technology and Research - Clalit Health — Herzliya
- Hadassah Medical Center — Jerusalem
- Meir Medical Center — Kfar Saba
- Schneider Children's Medical Center — Petah Tikva
- … and 5 more centers
Brazil · 10 centers
- Freire Pesquisa Clínica — Belo Horizonte
- Centro de Diabetes Curitiba — Curitiba
- Hospital Universitario Walter Cantidio — Fortaleza
- Cendi - Endocrinologia e Diabetes — Goiânia
- Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
- Universidade Federal do Rio de Janeiro — Rio de Janeiro
- Instituto de Pesquisa Clinica — São Paulo
- CPCLIN — São Paulo
- … and 2 more centers
Italy · 10 centers
- Ospedale Pediatrico Salesi — Ancona
- IRCCS - AOU di Bologna — Bologna
- Ospedale Microcitemico — Cagliari
- Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
- Ospedale San Raffaele — Milan
- University of Naples Federico II — Naples
- University of Naples Federico II — Naples
- Azienda Ospedaliero Universitaria Maggiore della Carità — Novara
- … and 2 more centers
United Kingdom · 10 centers
Center list to be confirmed — check the primary protocol.
Australia · 9 centers
- Women's and Children's Hospital — Adelaide
- Box Hill Hospital — Box Hill
- Royal Brisbane and Women's Hospital — Brisbane
- Centre for Children's Health Research — Brisbane
- Royal Children's Hospital — Melbourne
- The Royal Melbourne Hospital — Parkville
- Perth Children's Hospital — Perth
- Sydney Children's Hospital — Randwick
- … and 1 more center
France · 9 centers
- Hospices Civils de Lyon - Hopital Louis Pradel — Bron
- Centre Hospitalier Sud Francilien — Corbeil-Essonnes
- Hopital Claude Huriez - CHU de Lille — Lille
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
- Pitie Salpetriere University Hospital — Paris
- Hopitaux Universitaires Paris Centre-Hopital Cochin — Paris
- Hôpital Universitaire Necker Enfants Malades — Paris
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo — Paris
- … and 1 more center
Japan · 9 centers
- Abeno Medical Clinic — Abeno
- Saitama Medical University Hospital — Iruma
- Nippon Medical School Musashi Kosugi Hospital — Kawasaki
- Yamanashi Prefectural Central Hospital — Kofu
- Seino Internal Medicine Clinic — Kōriyama
- Jinnouchi Hospital — Kumamoto
- … and 3 more centers
United States · 7 centers
- Tallahassee Memorial HealthCare — Tallahassee
- University of South Florida — Tampa
- University of Iowa — Iowa City
- Iowa Diabetes and Endocrinology Research Center — West Des Moines
- Novak Center for Children's Health — Louisville
- Children's Hospital of Philadelphia (CHOP) — Philadelphia
- University of Virginia — Charlottesville
Belgium · 5 centers
- UZ Brussel — Brussels
- Cliniques universitaires Saint-Luc — Brussels
- Antwerp University Hospital — Edegem
- UZ Leuven — Leuven
- CHU UCL Namur/Site Sainte Elisabeth — Namur
Germany · 5 centers
- Klinik Josefinum — Augsburg
- Universitaetsklinikum Augsburg — Augsburg
- Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden — Dresden
- Hannoversche Kinderheilanstalt — Hanover
- TUM Klinikum — München
Norway · 5 centers
Center list to be confirmed — check the primary protocol.
Portugal · 5 centers
Center list to be confirmed — check the primary protocol.
Canada · 3 centers
- Alberta Children's Hospital — Calgary
- Alberta Diabetes Institute — Edmonton
- BC Diabetes Office — Vancouver
Finland · 3 centers
- Oulun yliopistollinen sairaala — Oulu
- Tampereen yliopistollinen sairaala — Tampere
- Turku University Hospital — Turku
Spain · 3 centers
Center list to be confirmed — check the primary protocol.
Poland · 2 centers
Center list to be confirmed — check the primary protocol.
Sweden · 2 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07222137 · 27404 · 2025-521797-34-00 · I4V-MC-JAJJ