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

300 patients around the world

Available in United States, Brazil

Eli Lilly and Company

9Research sites

300Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 1

Requirements for the patient

To 35 Years

All Gender

Medical requirements

: Have a new diagnosis of type 1 diabetes.
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.
Random C-peptide result >0.3 nmol/L (0.9 ng/mL) during the screening period.
Weigh at least 8 kilograms (kg) (18 pounds) at screening.

: 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.

Sites

IPEC - Instituto de Pesquisa Clínica

Rua Marquês de Itú 503, Cj 31, São Paulo, Sao Paulo

Centro de Diabetes Curitiba - Curitiba, Parana

Rua Alcidez Munhoz, 433, 4º andar, sala 448, Curitiba, Parana

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Campus Universitário S/N, Bloco G Subsolo II, Monte Alegre, Ribeirão Preto, Sao Paulo

Universidade Federal do Rio de Janeiro - Faculdade de Medicina - UFRJ

Bloco K - Av. Carlos Chagas Filho, 373 - 2º andar, Sala 49 - Cidade Universitária da Universidade Federal do Rio de Janeiro, Rio de Janeiro - RJ, 21044-020

CPClin – Centro de Pesquisas Clinicas LTDA

Avenida Angélica, 2162 – Consolação – São Paulo, SP, CEP:01228-200

Clínica Hepatogastro JK

Av. Pres. Juscelino Kubitschek, 1545 - Itaim Bibi, São Paulo - SP, 04543-011

Hospital das Clínicas da FMUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

Av. Dr. Enéas Carvalho de Aguiar, 155 - Cerqueira César, São Paulo - SP, 05403-000, Brazil

Quanta Diagnóstico por Imagem

R. Alm. Tamandaré, 1000 - Alto da XV, Curitiba - PR, 80045-170

Cedoes - Pesquisa e Diagnóstico

R. João da Silva Abreu, 78 - Praia do Canto, Vitória - ES, 29055-450

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Diabetes mellitus type 1

Requirements

To 35 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07222332