Abstract
Insulin therapy is still the gold standard in diabetic pregnancy. Insulin lispro protamine suspension is an available basal insulin analogue. Aim. To study pregnancy outcomes of women with type 2 and gestational diabetes mellitus when insulin lispro protamine suspension or human NPH insulin was added to medical nutrition therapy and/or short-acting insulin. Methods. In this retrospective study, for maternal outcome we recorded time and mode of delivery, hypertension, glycaemic control (fasting blood glucose and HbA1c), hypoglycemias, weight increase, and insulin need. For neonatal outcome birth weight and weight class, congenital malformations was recorded and main neonatal complications. Two-tail Student's t-test and chi-square test were performed when applicable; significant P < 0.05. Results. Eighty-nine pregnant women (25 with type 2 diabetes and 64 with gestational diabetes mellitus; 53 under insulin lispro protamine suspension and 36 under human NPH insulin) were recruited. Maternal and neonatal outcomes were quite similar between the two therapeutic approaches; however, insulin need was higher in NPH. At the end of pregnancy, eight women with gestational diabetes continued to use only basal insulin analogue. Conclusions. Pregnancy outcome in type 2 and gestational diabetes mellitus with insulin lispro protamine suspension was similar to that with NPH insulin, except for a lower insulin requirement.
Highlights
This is a multicentre retrospective observational study of a cohort of pregnant women affected by type 2 or gestational diabetes mellitus (GDM) which was not being effectively controlled with medical nutrition therapy (MNT) and/or rapid insulin analogues, who were treated with an intermediate-acting insulin (ILPS or neutral protamine Hagedorn (NPH))
Insulin lispro protamine suspension (ILPS) (ILPS group or ILPSg, n = 53) or NPH (NPH group or NPHg, n = 36) was introduced in addition to the current MNT ± rapid insulin analogues therapy when fasting plasma glucose was above the ADA goal
Because there was a higher number of women with type 2 diabetes in NPHg (χ2 0.0002), we separated those with type 2 diabetes from those with GDM; no significant differences of main clinical characteristics between treatment groups (ILPSg versus NPHg) at baseline were reported
Summary
Insulin therapy is still the gold standard in the treatment of diabetes in pregnancy when medical nutrition therapy (MNT) and lifestyle cannot reach and maintain the metabolic targets [1, 2].Studies using lispro and aspart in pregnancy have shown that both rapid-acting insulin analogues are safe and effective in reducing the postprandial glycaemia [3,4,5,6,7,8].human neutral protamine Hagedorn (NPH) insulin still remains the primary basal insulin choice [9,10,11,12,13], even though, recently, a randomized controlled trial demonstrated noninferiority of detemir versus NPH insulin in 310 pregnant women with type 1 diabetes [14].Insulin lispro protamine suspension (ILPS), formulated by cocrystallizing insulin lispro with protamine, is a basal insulin analogue with pharmacokinetics and glucodynamics comparable to those of NPH insulin [15]. There are no studies about ILPS use during pregnancy, during which the continuous adjustment of the hormonal pattern causes several metabolic and circulatory changes in the mother’s body to accommodate fetal needs [17], so its metabolic effectiveness in pregnancy has not yet been demonstrated. To this aim, we retrospectively studied pregnancies in women with type 2 and gestational diabetes mellitus (GDM) when
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