Recruiting NCT07222332

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

Phase III Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Baricitinib, Placebo.
Who it may be relevant to: Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 1 year — 35 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Canada +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

Drug Baricitinib
Administered orally
Drug Placebo
Administered orally

Primary outcome measures

Change from Baseline in C-peptide Area Under the Curve (AUC) [Time frame: Baseline, Week 52]

Secondary outcome measures (9)

Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 52]
Change from Baseline in Number of Manual Insulin Boluses [Time frame: Baseline, Week 52]
Rate of Clinically Significant Hypoglycemic Events [Time frame: Baseline through Week 52]
Change from Baseline in Fasting C-Peptide [Time frame: Baseline, Week 52]
Change from Baseline in Height [Time frame: Baseline, Week 52]
Change from Baseline in Mean Total Daily Insulin Dose [Time frame: Baseline, Week 52]
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2) [Time frame: Baseline, Week 52]
Change from Baseline in Matsuda Index [Time frame: Baseline, Week 52]
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [Time frame: Predose through Week 16]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

Brazil · 15 centers

Hospital Universitário Maria Aparecida Pedrossian — Campo Grande
Quanta Diagnóstico e Terapia — Curitiba
Centro de Diabetes Curitiba — Curitiba
Centro De Diabetes Metabolismo E Endocrinologia — Fortaleza
Cendi - Endocrinologia e Diabetes — Goiânia
Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
Instituto da Crianca com Diabetes — Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Pa — Ribeirão Preto
… and 7 more centers

Israel · 11 centers

Yitzhak Shamir Medical Center — Beer Yaacov
Soroka Medical Center — Beersheba
Rambam Health Care Campus — Haifa
Linn Medical Center — Haifa
Institute of Diabetes, Technology and Research - Clalit Health — Herzliya
Hadassah Medical Center — Jerusalem
Meir Medical Center — Kfar Saba
Schneider Children's Medical Center — Petah Tikva
… and 3 more centers

Australia · 10 centers

Women's and Children's Hospital — Adelaide
Centre for Children's Health Research — Brisbane
Austin Health - Repatriation Hospital — Heidelberg West
Ipswich Hospital — Ipswich
Royal Children's Hospital — Melbourne
Southern Adelaide Diabetes & Endocrine Services — Oaklands Park
The Royal Melbourne Hospital — Parkville
Perth Children's Hospital — Perth
… and 2 more centers

Italy · 10 centers