Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy.

Background: Pregnancy outcome in diabetic women is strictly related to glycemic control during pregnancy. The aim of our study was to compare pregnancy outcome between patients subjected to intensive insulin therapy using regular human insulin and those treated with insulin lispro (Humalog).

Material/methods: Group A (n=25) was treated with Humalog, and the control group B (n=46) with regular human insulin. Mean age, duration of diabetes, presence of chronic diabetic complications (according to the White classification) parity, and BMI did not differ between groups.

Results: The mean HbA1c concentrations in groups A and B were respectively: 7.8+/-1.4% vs. 7.5+/-1.5% in the first trimester, 6.4+/-0.8% vs. 6.5+/-1.6% in the second, and 6.7+/-0.7% vs. 6.3+/-1.2% in the third (no significant differences). The duration of pregnancy was 36.4+/-3.9 weeks in group A and 37.1+/-1.9 weeks in group B, while the mean neonatal birth weight was 3467+/-790 and 3367+/-666 g, respectively. Neither the frequency of preterm labor and cesarean section nor the frequency of fetal macrosomia and hypoglycemia differed between groups. There was only one malformed infant in the human insulin-treated group, and no statistical difference in the rate of spontaneous abortion between groups. Also, there were no differences in the frequencies of occurrence of hypertension (essential and pregnancy induced) and urinary tract infections.

Conclusions: The course of pregnancy and perinatal outcome is comparable in intensively treated diabetic women regardless of the short-acting insulin used. Humalog appears to be a safe alternative to human insulin in the treatment of diabetes during pregnancy.