A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
3 other identifiers
interventional
300
19 countries
132
Brief Summary
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2025
CompletedFirst Posted
Study publicly available on registry
October 29, 2025
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 17, 2026
April 1, 2026
2.4 years
October 27, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in C-peptide Area Under the Curve (AUC)
Baseline, Week 52
Secondary Outcomes (9)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events
Baseline through Week 52
Change from Baseline in Fasting C-Peptide
Baseline, Week 52
Change from Baseline in Height
Baseline, Week 52
- +4 more secondary outcomes
Study Arms (2)
Baricitinib
EXPERIMENTALParticipants will receive baricitinib orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
- Have at least one diabetes-related autoantibody found at screening
- Show signs of remaining beta-cell function
- stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
- Weigh at least 8 kilograms (kg) (18 pounds) at screening
You may not qualify if:
- Have any other type of diabetes including gestational
- 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 medical condition or infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (132)
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Women's and Children's Hospital
Adelaide, 5006, Australia
Centre for Children's Health Research
Brisbane, 4101, Australia
Austin Health - Repatriation Hospital
Heidelberg West, 3081, Australia
Ipswich Hospital
Ipswich, 4305, Australia
Royal Children's Hospital
Melbourne, 3052, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, 5046, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
Perth Children's Hospital
Perth, 6009, Australia
Sydney Children's Hospital
Randwick, 2031, Australia
The Children's Hospital at Westmead
Westmead, 2145, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, 5530, Belgium
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, 79080-190, Brazil
Quanta Diagnóstico e Terapia
Curitiba, 80045170, Brazil
Centro de Diabetes Curitiba
Curitiba, 80810-040, Brazil
Centro De Diabetes Metabolismo E Endocrinologia
Fortaleza, 60175-047, Brazil
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072, Brazil
Instituto da Crianca com Diabetes
Porto Alegre, 91350-250, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
Ribeirão Preto, 14051-140, Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941-590, Brazil
Instituto de Pesquisa Clinica
São Paulo, 01223-001, Brazil
CPCLIN
São Paulo, 01228-200, Brazil
IBTED - Tecnologia e Educação em Diabetes
São Paulo, 04038-032, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
Hospital das Clinicas FMUSP
São Paulo, 05403-000, Brazil
CEDOES
Vitória, 29055450, Brazil
Alberta Children's Hospital
Calgary, T3B 6A8, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6, Canada
Alberta Diabetes Institute
Edmonton, T6G 2E1, Canada
St. Joseph's Health Care
London, N6A 4V2, Canada
Centricity Research Ottawa LMC Endocrinology
Ottawa, K2J 0V2, Canada
CHUL et Centre mère-enfant Soleil
Québec, G1V 4G2, Canada
BC Diabetes Office
Vancouver, V5Y 3W2, Canada
Nemocnice Jihlava
Jihlava, 58633, Czechia
Fakultni nemocnice Ostrava
Ostrava, 70852, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900, Czechia
New Children's Hospital
Helsinki, 00029, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
Turku University Hospital
Turku, 20520, Finland
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38700, France
Hopital Claude Huriez - CHU de Lille
Lille, 59037, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385, France
Pitie Salpetriere University Hospital
Paris, 75013, France
Hôpital Universitaire Necker Enfants Malades
Paris, 75015, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, 75019, France
CHU Rangueil
Toulouse, 31059, France
Hannoversche Kinderheilanstalt
Hanover, 30173, Germany
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
Hof, 95030, Germany
Klinikum Karlsburg
Karlsburg, 17495, Germany
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, 67059, Germany
TUM Klinikum
München, 80939, Germany
RED-Institut GmbH
Oldenburg, 23758, Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
Yitzhak Shamir Medical Center
Beer Yaacov, 70300, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Linn Medical Center
Haifa, 3515209, Israel
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, 4600201, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Medical Center
Tel Aviv, 6423906, Israel
Ospedale Pediatrico Salesi
Ancona, 60123, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139, Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125, Italy
Ospedale San Raffaele
Milan, 20132, Italy
University of Naples Federico II
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100, Italy
Azienda Ospedale - Università Padova
Padova, 35128, Italy
Azienda Ospedale - Università Padova
Padova, 35128, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
Diabeter - Rotterdam
Rotterdam, 3011 TA, Netherlands
Helse Fonna - Haugesund Sjukehus
Haugesund, 5528, Norway
Akershus Universitetssykehus
Lørenskog, 1478, Norway
Oslo Universitetssykehus Aker
Oslo, 0316, Norway
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
Stavanger Universitetssykehus
Stavanger, 4011, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
UMED Clinical Trials
Lodz, 92-213, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, 50-368, Poland
2Ca Braga
Braga, 4710-243, Portugal
Centro Materno Infantil do Norte
Porto, 4050, Portugal
ULSAM - Hospital de Santa Luzia
Viana do Castelo, 4900-858, Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
ProbarE i Lund AB
Lund, 222 22, Sweden
Universitetssjukhuset Örebro
Örebro, 701 85, Sweden
Östersunds Sjukhus
Östersund, 831 31, Sweden
ProbarE i Stockholm AB
Stockholm, 11437, Sweden
Uddevalla Sjukhus
Uddevalla, 451 53, Sweden
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev, 04114, Ukraine
Kyiv City Endocrinological Center
Kyiv, 01024, Ukraine
Zakarpattia Endoclinic
Uzhhorod, 88000, Ukraine
Vinnytsia Regional Clinical Endocrinology Dispensary
Vinnytsia, 21010, Ukraine
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2025
First Posted
October 29, 2025
Study Start
February 5, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.