Australian medical research institute started a clinical trail of a Baricitinib in New-onset Type 1 Diabetes
St Vincent's Institute of Medical Research is commencing recruitment for the clinical trial of the Baricitinib in New-onset Type 1 Diabetes.
The condition is Type 1 Diabetes.
A new clinical trial is recruiting patients in the following locations: Australia.
The trial officially began on the October 30, 2020 and is planned to complete on October 31, 2024.
Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by cells of the immune system. The study aims to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation. The investigators have identified a pathway that is important for immune cells to kill beta cells, and a drug that will block this pathway and prevent beta cell death. This drug, baricitinib, is already in clinical use for rheumatoid arthritis, and is currently in clinical trials for other diseases, including childhood autoimmune diseases. It is hypothesized that baricitinib treatment for 48 weeks will preserve beta cell function in children and young adults with recently-diagnosed T1D.
Among the inclusion criteria are:
- Male or female aged between 12 and 30 years (inclusive) at screening.
- Diagnosis of T1D according to ADA criteria within 100 days prior to starting study drug.
- Islet autoantibody positivity (one or more of: GADA, IA-2A, IAA (assessed within one week of commencing insulin therapy), ZnT8A).
- Stimulated (peak or 90 min) C-peptide >0.2 nM during a 2-hour MMTT at the screening visit.
- Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study.
Juvenile Diabetes Research Foundation and Juvenile Diabetes Research Foundation Australia are the collaborators in this clinical trial.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04774224
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