A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-35
SponsorEli Lilly and Company

About this trial

The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening

Have Stage 1b or Stage 2 type 1 diabetes

Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening

Disqualifiers

Have any other type of diabetes

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baricitinib

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: BaricitinibExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes

Time frame
Baseline up to approximately 5 years

Secondary outcomes

1

Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)

Time frame
Baseline, Week 52
2

Change from Baseline in Glucose AUC

Time frame
Baseline, Week 52
3

Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)

Time frame
Baseline, Week 52
4

Change from Baseline in Height

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

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