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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Baricitinib; Drug: Placebo

• Registration Number: NCT07222332
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-10-27
• Study First Posted: 2025-10-29
• Last Update Submitted: 2025-10-29
• Last Update Posted: 2025-10-30
• Study Start: 2026-03-01
• Primary Completion: 2028-07
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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, or
  • 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib	Participants will receive baricitinib orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Change from Baseline in C-peptide Area Under the Curve (AUC)	Baseline, Week 52

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses	Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events	Baseline through Week 52	Measured by continuous glucose monitoring and serious adverse event reporting
Change from Baseline in Fasting C-Peptide	Baseline, Week 52
Change from Baseline in Height	Baseline, Week 52
Change from Baseline in Mean Total Daily Insulin Dose	Baseline, Week 52	Measured during the two weeks prior to the assessment
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)	Baseline, Week 52
Change from Baseline in Matsuda Index	Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib	Predose through Week 16

Trial Locations

Locations (130)

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States

Children's Hospital of Philadelphia (CHOP); 🇺🇸 Philadelphia, Pennsylvania, United States

Driscoll Children's Hospital; 🇺🇸 Corpus Christi, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Women's and Children's Hospital; 🇦🇺 Adelaide, Australia

Centre for Children's Health Research; 🇦🇺 Brisbane, Australia

Austin Health - Repatriation Hospital; 🇦🇺 Heidelberg West, Australia

Ipswich Hospital; 🇦🇺 Ipswich, Australia

Royal Children's Hospital; 🇦🇺 Melbourne, Australia

Southern Adelaide Diabetes & Endocrine Services; 🇦🇺 Oaklands Park, Australia

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