Objective: To investigate the prevalence of insulin antibody (IA) formation among patients with type 2 diabetes receiving insulin therapy and their clinical characteristics.

Research Design and Methods: IA formation was evaluated using a polyethylene glycol (PEG) precipitation assay in 726 patients with type 2 diabetes (396 on insulin therapy and 330 who had never used insulin), and 87 nondiabetes controls. Risk factors for IA formation were analyzed by logistic regression.

Results: IAs were detected in 154 of the 396 type 2 diabetes patients on insulin therapy (38.9%). IA formation was independently associated with fasting insulin concentration or insulin/C-peptide ratio, IA titers and the incidence of hypoglycemia. The area under ROC curve for fasting insulin/C-peptide ratio in predicting IA formation was 0.830, indicating good diagnostic performance. The insulin/C-peptide ratio cutoff value of 9.3 uIU/ng(Figure 1)showed a sensitivity of 78% and specificity of 73% for predicting the presence of IAs.

Conclusions: Our findings suggest that IA formation should be suspected if insulin-treated diabetes patients experience frequent hypoglycemia, and that the fasting insulin/C-peptide ratio can be used to detect IA formation. Our study thus provides the foundation for developing more clinically convenient methods for identifying IAs in insulin-treated type 2 diabetes patients.


L. Zhou: None. Y. Luo: None. X. Cai: None. X. Han: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi.

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