Insulin lispro and regular insulin in pregnancy

Abstract

We assessed the safety of insulin lispro in gestational, type 1 and type 2 diabetes mellitus, analysing 635 pregnancies over a period of 7 years. We also evaluated patient satisfaction, sending an internationally-accepted anonymous diabetes treatment satisfaction questionnaire to 22 patients (three type 1, 19 gestational diabetes) who received regular and lispro insulin in successive pregnancies. The success rate of pregnancies in women with gestational diabetes managed with diet alone (n=325) was 99.3%. All 213 pregnancies in women with gestational diabetes requiring insulin were successful. There was no difference in maternal or fetal outcomes whether patients used regular insulin (n=138) or insulin lispro (n=75), but pre-delivery HbA1c was lower with insulin lispro (p<0.05). Pregnancy loss in patients with pre-gestational diabetes (89 pregnancies in type 1 and eight in type 2 diabetes) was 18.6% for insulin and 3.7% for insulin lispro (p=0.10). The incidences of congenital anomalies with regular insulin were 7.9% and 15.8% in gestational and pre-gestational diabetes, respectively; the figures for insulin lispro were 6.6% (p=0.79) and 3.8% ( p=0.16), respectively. Nineteen of the 22 surveyed patients completed the questionnaire. Satisfaction was higher with insulin lispro (26.3+/-2.3 vs. 18+/-8.9, p=0.0005). We found no increase in adverse outcome using lispro insulin in diabetic pregnancies, in either gestational or pre-gestational diabetes. Patient satisfaction favoured insulin lispro. Several patients with type 1 diabetes who used regular insulin during pregnancy, chose lispro after delivery, but all who used lispro in pregnancy preferred to continue.

Systematic Literature Review of Basal Bolus Insulin Analogue Therapy during Pregnancy

“…As suggested by these results glycemic control measured by A1c was improved in lispro groups versus regular insulin in multiple studies [22,23,26,29], except for the Garcia-Dominguez et al [30] report showing greater A1c levels in the lispro group, p=0.022 [30].…”

“…However, predelivery A1c levels in the lispro group were significantly lower than regular insulin and diet-controlled groups (p<0.05). In addition, patient satisfaction was significantly higher in the lispro group compared to regular insulin (26.3±2.3 vs. 18±8.9, p=0.0005) [22].…”

“…Overall, there were no statistically significant differences in glycemic control between the 2 groups during pregnancy and postpartum [21]. Similarly, Bhattacharyya et al [22] conducted a retrospective cohort study of PGDM and GDM patients and demonstrated no differences in fetal outcomes. However, predelivery A1c levels in the lispro group were significantly lower than regular insulin and diet-controlled groups (p<0.05).…”

Insulin Aspart in Diabetic Pregnancy: State of the Art

“…Several small observational or randomized studies using insulin lispro during future science group future science group www.futuremedicine.com pregnancy have been published [31][32][33][34][35][36][37][38][39]. The offspring of 496 women treated with insulin lispro before and during pregnancy have been carefully investigated retrospectively, demonstrating a rate of major congenital malformations of 5.4%, comparable to other large-scale studies of pregnant women receiving regular human insulin [39].…”

Treatment With Insulin and Its Analogs in Pregnancies Complicated by Diabetes

“…In a large clinical trial among 213 patients who had GDM (14) and received insulin therapy (regular insulin, n ϭ 138; lispro, n ϭ 75), there were no significant differences in maternal or fetal outcomes and no increase in adverse events using lispro, but predelivery A1C values were lower and patient satisfaction was higher for insulin lispro (P Ͻ 0.05).…”