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Recruiting Phase 3 NCT07222332

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

Phase 3 – large-scale trial before approval
Conditions: Diabetes Mellitus, Type 1

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 18
Australia (1)
Women's and Children's Hospital
Adelaide
Belgium (1)
Université Libre de Bruxelles - Hôpital Erasme
Brussels
NOT_YET_RECRUITING
Brazil (1)
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande
NOT_YET_RECRUITING
Canada (1)
Alberta Children's Hospital
Calgary
NOT_YET_RECRUITING
Czech Republic (1)
Nemocnice Jihlava
Jihlava
Finland (1)
New Children's Hospital
Helsinki
NOT_YET_RECRUITING
France (1)
Hospices Civils de Lyon - Hopital Louis Pradel
Bron
NOT_YET_RECRUITING
Germany (1)
Hannoversche Kinderheilanstalt
Hanover
NOT_YET_RECRUITING
Israel (1)
Yitzhak Shamir Medical Center
Beer Yaacov
Italy (1)
Ospedale Pediatrico Salesi
Ancona
NOT_YET_RECRUITING
Netherlands (1)
Diabeter - Rotterdam
Rotterdam
NOT_YET_RECRUITING
Norway (1)
Helse Fonna - Haugesund Sjukehus
Haugesund
NOT_YET_RECRUITING
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Spain (1)
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo
Sweden (1)
ProbarE i Lund AB
Lund
NOT_YET_RECRUITING
Ukraine (1)
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev
United Kingdom (1)
Aberdeen Royal Infirmary
Aberdeen
United States (1)
Barbara Davis Center for Childhood Diabetes
Aurora , Colorado
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
35 Years
Healthy volunteers
No
Start date
05.02.2026
Completion date
01.07.2028
Registry ID
NCT07222332
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.