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Type 1 diabetes is caused by autoimmune-mediated destruction of β cells
Imatinib (Gleevec) is a tyrosine kinase inhibitor that has been successfully used in the treatment of chronic myeloid leukemia (CML) for many years.
"Lancet - Diabetes and Endocrinology" earlier commentary pointed out, "This is the (impact) assessment for the first time in human type 1 diabetes tyrosine kinase inhibitor"
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial
The study reached its primary endpoint
▲In the MMTT test, the area under the C-peptide response curve of the imatinib group (blue) and the placebo group (red) for 2 hours
The two groups used similar exogenous insulin at baseline.
▲Exogenous insulin dose and HbA1c level of imatinib group (blue) and placebo group (red)
The secondary and exploratory analysis did not observe a significant effect of imatinib treatment on the immune response, but it did show that imatinib has a series of unique effects on metabolism, including improved β-cell function and insulin sensitivity
In terms of safety, imatinib is generally well tolerated.
During the 24-month follow-up period, 71% (32/45) of patients in the imatinib treatment group experienced grade 2 or more serious adverse events, compared with 59% (13/22) in the placebo group
The most common adverse events (Grade 2 or more severe) that differed between the two groups included:
Gastrointestinal problems: The incidence of imatinib group was 13%, mainly nausea, and no placebo group occurred; additional laboratory investigation: 22% of imatinib group vs 9% of placebo group
According to the trial protocol, 17 patients (38%) in the imatinib group and 5 (23%) patients in the placebo group required temporary adjustment of the drug dose; 6 patients (13%) in the imatinib group stopped due to adverse events No one in the placebo group discontinued the drug
Note: The original text has been deleted
Reference
[1] Stephen E Gitelman, et al.
[2] Jay S Skyler.