Clinical Trials in France / NCT07222332
Recruiting
Phase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
NCT07222332 · tracked via the Priya Life Science France tracker
Condition(s) studied
Diabetes Mellitus, Type 1
Investigational drug(s) / intervention(s)
Baricitinib →Placebo
Baricitinib: Administered orally
Placebo: Administered orally
Study 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.
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
- Change from Baseline in C-peptide Area Under the Curve (AUC) — Baseline, Week 52
Trial sites (131)
| Facility | City | Region | Status |
|---|---|---|---|
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | Recruiting |
| Tallahassee Memorial HealthCare | Tallahassee | Florida | Recruiting |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Driscoll Children's Hospital | Corpus Christi | Texas | Recruiting |
| University of Virginia | Charlottesville | Virginia | Recruiting |
| Women's and Children's Hospital | Adelaide | Australia | Recruiting |
| Centre for Children's Health Research | Brisbane | Australia | Not Yet Recruiting |
| Austin Health - Repatriation Hospital | Heidelberg West | Australia | Recruiting |
| Ipswich Hospital | Ipswich | Australia | Recruiting |
| Royal Children's Hospital | Melbourne | Australia | Not Yet Recruiting |
| Southern Adelaide Diabetes & Endocrine Services | Oaklands Park | Australia | Recruiting |
| The Royal Melbourne Hospital | Parkville | Australia | Recruiting |
| Perth Children's Hospital | Perth | Australia | Recruiting |
| Sydney Children's Hospital | Randwick | Australia | Recruiting |
| The Children's Hospital at Westmead | Westmead | Australia | Recruiting |
| Université Libre de Bruxelles - Hôpital Erasme | Brussels | Belgium | Not Yet Recruiting |
| UZ Brussel | Brussels | Belgium | Recruiting |
| Cliniques universitaires Saint-Luc | Brussels | Belgium | Not Yet Recruiting |
| Antwerp University Hospital | Edegem | Belgium | Recruiting |
| UZ Gent | Ghent | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège | Belgium | Recruiting |
| CHU UCL Namur/Site Sainte Elisabeth | Namur | Belgium | Recruiting |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Yvoir | Belgium | Recruiting |
| Hospital Universitário Maria Aparecida Pedrossian | Campo Grande | Brazil | Recruiting |
| Quanta Diagnóstico e Terapia | Curitiba | Brazil | Recruiting |
| Centro de Diabetes Curitiba | Curitiba | Brazil | Recruiting |
| Centro De Diabetes Metabolismo E Endocrinologia | Fortaleza | Brazil | Recruiting |
| Cendi - Endocrinologia e Diabetes | Goiânia | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM | Marília | Brazil | Recruiting |
| Instituto da Crianca com Diabetes | Porto Alegre | Brazil | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T | Ribeirão Preto | Brazil | Recruiting |
| Universidade Federal do Rio de Janeiro | Rio de Janeiro | Brazil | Recruiting |
| Instituto de Pesquisa Clinica | São Paulo | Brazil | Recruiting |
| CPCLIN | São Paulo | Brazil | Recruiting |
| IBTED - Tecnologia e Educação em Diabetes | São Paulo | Brazil | Recruiting |
| Clínica Hepatogastro JK | São Paulo | Brazil | Recruiting |
| Hospital das Clinicas FMUSP | São Paulo | Brazil | Recruiting |
| CEDOES | Vitória | Brazil | Recruiting |
| Alberta Children's Hospital | Calgary | Canada | Not Yet Recruiting |
+ 91 more sites — see the full list on the official registry below.
On this site
📄 Olumiant (baricitinib) drug profile →More Eli Lilly and Company trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07222332 on ClinicalTrials.gov ↗ ← All trials in France