Metabolic and immunologic effects of insulin lispro in gestational diabetes

OBJECTIVE - To compare the immunologic response to insulin lispro with that to regular human insulin, thereby assuring its safety far use in women wit h gestational diabetes, and to verify that it is effective. RESEARCH DESIGN AND METHODS - We compared the metabolic and immunologic effects of i nsulin lispro and regular human insulin in 42 women >18.)rears of age diagn osed with gestational diabetes by oral glucose tolerance testing at 14-32 w eeks of gestation. Patients were randomized to receive regular human insuli n or insulin lispro before consuming a test meal. Serum insulin, blood gluc ose, and C-peptide concentrations were measured. Throughout the remainder o f gestation, patients received premeal insulin lispro or regular human insu lin combined with basal insulin and performed blood glucose self-monitoring before and after each meal. Insulin antibodies and HbA(1c) were determined at enrollment and 6 weeks later. In addition, 10 patients received continu ous intravenous insulin (4 lispro, 6 regular human insulin) and dextrose in fusions intrapartum to assess placental insulin transfer. RESULTS - Anti-insulin antibody levels were similar in the two groups. Insu lin lispro was not detectable in the cord blood. During a meal test, areas under the curve for glucose, insulin, and C-peptide were significantly lowe r in the lispro group. Mean fasting and postprandial glucose concentrations and end point HbA(1c) were similar in the two groups. The lispro group dem onstrated fewer hypoglycemic episodes (symptoms and blood glucose concentra tions (<55 mg/dl). Na fetal or neonatal abnormalities were noted in either treatment group. CONCLUSIONS - Insulin lispro may be considered a treatment option for women with gestational diabetes.