1147-P: Effect of Short-Term Ciclosporin A Treatment on Insulin Secretion in Patients with Adult-Onset Autoimmune Diabetes: An Open-Label, Single-Arm, Pilot Study in China

Abstract

Adult-onset autoimmune diabetes, defined as having latent autoimmune diabetes in adults (LADA), is characterized by a less intensive autoimmune process, in which a lymphocytic infiltration of the exocrine pancreas is involved. Immunosuppressive agents may have potential therapeutic benefit. This is a pilot study examining the therapeutic effects of oral administration of ciclosporin A on insulin secretion in patients with LADA. The study was an open label, single arm, pilot trial. A total of 12 patients (8 men and 4 women with mean age of 40.2 years old) diagnosed with LADA were prospectively evaluated. All patients underwent insulin treatment at least for 3 months without any oral anti-hyperglycemic agent. Serum C-peptide concentrations were measured at baseline and after ciclosporin A intervention. We also evaluated clinical parameters including total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine (Cre) before and after ciclosporin A treatment. The primary outcome of the study was the change in serum C-peptide concentrations. A total of 12 patients completed the study. No patient was withdrawn. Serum fasting C-peptide concentrations significantly increased from 0.10 ng/ml up to 0.32 ng/ml, following treatment with ciclosporin A (50mg/day) for 4 weeks (P<0.001). After 4-week ciclosporin A intervention, there was no significant difference on TBIL (14.33 vs. 13.70 umol/L, P=0.59), DBIL(4.31 vs. 4.63 umol/L, P=0.48), AST(16.83 vs. 18.50 U/L, p=0.09), ALT(17.17 vs. 18.16 U/L, p=0.35), or Cre (67.17 vs. 66.01 umol/L, P=0.25) compared with the corresponding baseline levels. This pilot study demonstrates the potential therapeutic effects of oral administration of ciclosporin A for patients with LADA. No significant adverse effects of the drug were observed. Larger, controlled studies are needed to verify the results. Disclosure L. Zhang: None. J. Wang: None. N. Wang: None. Y. Yang: None. X. Yin: None. Y. Dong: None.