BARICADE-PRESERVE study
Preserving β-cell Function with Baricitinib in Newly Diagnosed Type 1 Diabetes
Background and Rationale
Type 1 diabetes (T1D) is an autoimmune disease in which the immune system progressively destroys the insulin-producing β-cells in the pancreas. At the time of diagnosis, however, a proportion of functioning β-cells usually remains. Preserving this residual β-cell function may help maintain endogenous insulin production and could contribute to improved glycaemic control and diabetes management. BARICADE-PRESERVE is an international phase III clinical trial, sponsored by Lilly, investigating whether baricitinib can preserve β-cell function in children, adolescents and adults who have recently been diagnosed with type 1 diabetes.
Baricitinib is a Janus kinase (JAK) inhibitor that modulates signalling pathways involved in immune and inflammatory responses. It is already approved for the treatment of several immune-mediated diseases. By targeting pathways involved in the autoimmune response, baricitinib may have the potential to slow the loss of insulin-producing β-cells after the diagnosis of type 1 diabetes.
By participating in BARICADE-PRESERVE, Diabetercontributes to international research exploring treatments that go beyond glucose management and aim to modify the underlying autoimmune disease process, with the goal of preserving the body’s remaining insulin production.
Study Objectives
The BARICADE-PRESERVE study aims to investigate:
- Whether treatment with baricitinib can preserve endogenous insulin production and β-cell function in people recently diagnosed with type 1 diabetes compared with placebo.
- The effects of baricitinib on glycaemic control and other diabetes-related outcomes.
- The effects of treatment on markers of immune function.
- The pharmacokinetics and pharmacodynamics of baricitinib in children and adults with newly diagnosed type 1 diabetes.
- The safety and tolerability of baricitinib in this population.
Study Design & Study Population
BARICADE-PRESERVE is a randomized, double-blind, placebo-controlled phase III study with an intended enrolment of approximately 300 participants worldwide.
The study includes children, adolescents and adults aged 1 to 35 years with a recent diagnosis of type 1 diabetes. Study treatment must be started within 100 days of diagnosis. Participants must also have at least one diabetes-associated autoantibody at screening and meet additional eligibility criteria.
Following screening, eligible participants are randomly assigned to receive either baricitinib or placebo. Neither participants nor the study team know which treatment is being given during the blinded study period. Baricitinib is taken once daily, either as a tablet or oral solution.
Participation in the study lasts approximately 60 weeks.
Study Procedures and Data Collection
During the study, participants undergo regular assessments to evaluate the effect and safety of treatment. These include:
- Assessment of residual β-cell function and endogenous insulin production, including measurement of C-peptide responses.
- Evaluation of glycaemic control and diabetes-related outcomes.
- Blood sampling to assess immune and inflammatory markers.
- Pharmacokinetic and pharmacodynamic assessments to study how baricitinib is processed by and acts within the body.
- Safety assessments throughout the study period.