Basal Insulin Analogs versus Neutral Protamine Hagedorn for Type 2 Diabetics

Abstract

Objective To determine whether basal insulin analogs reduce the rate of composite neonatal morbidity compared with neutral protamine Hagedorn (NPH) in women with type 2 diabetes mellitus (T2DM). Study Design This was a retrospective cohort study of women with T2DM and singleton pregnancy at a single tertiary center. Primary outcome was a composite neonatal morbidity of any of the following: shoulder dystocia, large for gestational age, neonatal intensive care unit admission, neonatal hypoglycemia, or respiratory distress syndrome. Secondary outcomes were rates of maternal hypoglycemic events, hypertensive disorders, preterm birth, and primary cesarean delivery. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated. Results Of 233 women with T2DM that met the inclusion criteria, 114 (49%) were treated with basal insulin analogs and 119 (51%) with NPH. The rate of composite neonatal morbidity was similar between groups (73 vs. 60%; aRR: 1.18; 95% CI: 0.92–1.51). There were no differences in the rates of maternal adverse outcomes between the groups. Basal insulin analog was associated with a lower rate of primary cesarean delivery as compared with NPH (21 vs. 36%; aRR: 0.44; 95% CI: 0.25–0.78). Conclusion Among pregnant women with T2DM managed with either basal or NPH insulin regimen, the rates of composite neonatal morbidity and maternal complications were similar.

Comparison of treatment with insulin detemir and NPH in women with gestational diabetes mellitus: glycemic control and pregnancy outcomes. A retrospective study

“…No allergic reactions were recorded in our study in the two treatment arms. According to most previous studies, adverse drug reactions were rare and similar between the NPH and detemir groups [16,21,22,24]. Notably, in the study by Mathiesen et al, only eight women of the 152 of the detemir group reported adverse events relating to injection sites [8].…”

“…Furthermore, no hypertensive disorders were recorded in either group. Previous studies comparing insulin detemir versus NPH in pregnancies with T1DM, T2DM, or GDM have shown comparable rates of hypertension [9,16,21,24]. Only the aforementioned RCT in pregnant women with T2DM observed lower adverse maternal outcomes, including hypertensive disorders, in the detemir group compared to the NPH group [22].…”

“…Insulin detemir or NPH was injected once daily, while there was no need for rapidacting insulin. In two observational studies investigating insulin NPH versus detemir in pregnancies with T2DM or GDM, the rate of hypoglycemia between the two groups was comparable [21,24]. However, in the RCT by Herrera et al in 87 pregnant women with GDM and T2DM, NPH was associated with a higher risk of hypoglycemia compared to insulin detemir.…”

Insulin Use During Gestational and Pre-existing Diabetes in Pregnancy: A Systematic Review of Study Design

“…Among women diagnosed with GDM, across different interventions, retrospective analyses revealed that cases of cesarean section and preterm delivery were higher in women managed with insulin than in those managed with other interventions such as diet/MNT, metformin and metformin + insulin [ 28 , 32 , 45 , 46 ]. Compared with other interventions, insulin did not show a significant difference in the rate of gestational hypertension and induced labor in women treated with insulin and those managed with lifestyle modification [ 47 , 48 ] or metformin [ 49 , 50 ]. In the mixed population, a prospective cohort study by Negrato et al compared insulin glargine with NPH and reported a significantly higher rate of preeclampsia in the NPH-treated group compared to the glargine-treated group ( p < 0.0001) in women diagnosed with diabetes prior to pregnancy [ 51 ].…”

“…Most of the studies did not report stillbirth, with only five studies reporting this outcome. Perinatal mortality among women with pre-existing diabetes was reported in retrospective studies by Bartal et al, Abell et al and Billionnet et al, and no differences across the treatment arms were observed [ 48 , 62 , 63 ]. However, in a prospective cohort study by Negrato et al, a significantly higher rate of perinatal mortality ( p = 0.028) in pregnant women diagnosed with diabetes prior to pregnancy was reported among NPH-treated women compared to those treated with glargine [ 51 ].…”