engleski

A randomised, controlled, trial comparing insulin detemir with NPH insulin in pregnant women with type 1 diabetes

A prospective, randomised, controlled, parallel- group, open-label trial comparing insulin detemir (IDet) vs. NPH (both with prandial insulin aspart) in pregnant women with type 1 diabetes (T1DM). Methods: T1DM women (HbA1c
8 % at pregnancy confirmation) were randomised to IDet (n=152) or NPH (n=158) up to 12 months before pregnancy or at 8- 12 weeks gestation. Results: Women pregnant at randomisation: IDet n=79, NPH n=83 ; women pregnant after randomisation: IDet n=73, NPH n=75. Mean±SD demographics: age 30.1±4.4 yrs ; BMI 24.8±4.1 kg/m2 ; HbA1c 7.01±0.79% ; fasting plasma glucose (FPG) 5.94±3.25 mmol/l and diabetes duration 12.3±8.0 yrs. Estimated HbA1c (FAS) at GW36 was 6.27% (IDet) and 6.33% (NPH). IDet was non-inferior to NPH and not superior (FAS: -0.06, 95% CI: -0.21 ; 0.08 ; PP: -0.151 ; 95% CI: -0.34 ; 0.04). Estimated FPG was significantly lower with IDet vs. NPH at GW 24 (5.38 vs. 6.32 mmol/l, difference -0.94 [-1.67 ; -0.21], p=0.012) and at GW 36 (4.76 vs. 5.41 mmol/l, difference -0.65 [-1.19 ; -0.12], p=0.017). The rate of major hypoglycaemia (events/yr) was 1.1 for IDet vs. 1.2 for NPH. Hypoglycaemic events between treatments were statistically and clinically comparable. Neonatal outcome were similar in the two groups: Gestational age at delivery (weeks), mean (SD): IDet=38.2 (1.9), NPH=37.8 (1.5) ; Preterm delivery (<37 weeks), n(%): IDet=26 (20%), NPH=36 (27%) ; Large for gestational age (>90th percentile), n (%): IDet=59 (46%) NPH=73 (54%): congenital malformations: IDet=8, NPH=9 ; perinatal deaths: IDet=1, NPH=1. Conclusions: Insulin detemir results in comparable HbA1c, but lower FPG (relative to NPH) in women in late pregnancy with type 1 diabetes. With respect to perinatal morbidity and mortality, IDet is as welltolerated as NPH.

Insulin detemir; NPH; type-1 diabetes

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