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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, Belgium, Spain

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 de Ribeirão Preto

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

Rocco & Nazato Serviços Médicos Ltda (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