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Maternal Efficacy and Safety Outcomes in a Randomized Trial Comparing Insulin Detemir with NPH Insulin in 310 Pregnant Women with Type 1 Diabetes

Results: The aim of this prospective, randomized, controlled, parallel-group, open-label trial was to compare the efficacy and safety of insulin detemir (IDet) vs. NPH (both with prandial insulin aspart) in pregnant women with type 1 diabetes (T1DM). T1DM women (HbA1c ≤8 % at pregnancy confirmation) were randomized to IDet (n=152) or NPH (n=158) up to 12 months before pregnancy or during pregnancy at 8-12 weeks gestation. The primary objective was to confirm efficacy of IDet by showing that IDet was non-inferior to NPH with respect to HbA1c at 36 gestational weeks (GWs) (primary endpoint). Non-inferiority was shown if the upper limit of the 95% CI for the treatment difference of IDet vs. NPH was below the pre-specified non-inferiority margin of 0.4% for both the Full Analysis Set (FAS) and Per Protocol Set (PP). The data were analyzed using linear regression. 79 and 83 women in the IDet and NPH groups, respectively, were pregnant at randomization while 73 and 75 women, respectively, became pregnant following randomization. Mean±SD baseline demographics were: 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. For FAS, the estimated HbA1c at GW36 was 6.27% for IDet and 6.33% for NPH. IDet was declared non-inferior to NPH (FAS: -0.06%, 95% CI: -0.21 ; 0.08 ; PP: -0.151% ; 95% CI: -0.34 ; 0.04). FPG was significantly lower with IDet vs. NPH (table). Hypoglycemia rates were similar between groups. In summary, lower FPG, but comparable HbA1c in late pregnancy were obtained using insulin detemir in comparison to NPH insulin in women with type 1 diabetes.

Detemir; HPH insulin; perinatal outcome

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