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Maternal efficacy and safety outcomes ina a radnomized trial comparing insulin detemir with NPH insulin in 313 pregnant women with type 1 diabetes

The aim of this prospective, randomized, controlled, parallel-group, open-label trial as to compare the efficacy and safety of insulin detemir (IDet) vs. NPH (both ith prandial insulin aspart) in pregnant vvomen ith type 1 diabetes (T1DM). T1DM vvomen (HbA1c <8 % at pregnancy confirmation) ere randomized to IDet (n=152) or NPH (n=161) up to 12 months before pregnancy or during pregnancy at 8-12 eeks gestation. The primary objective as to confirm efficacy of IDet by shovving that IDet as non-inferior to NPH ith respect to HbA1c at 36 gestational vveeks (GVVs) (primao/ endpoint). Non-inferiority as shovvn if the upper limit of the 95% Cl for the treatment difference of IDet vs. NPH as belovv the pre-specified non-inferior^ margin of 0.4% for both the Full Analysis Set (FAS) and Per Protocol Set (PP). The data ere analvzed using linear regression. 79 and 83 vvomen in the IDet and NPH groups, respectively, ere pregnant at randomization vvhile 73 and 75 vvomen, respectively, became pregnant follovving randomization. Mean (SD) baseline demographics ere: 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 GVV36 as 6.27% for IDet and 6.33% for NPH. IDetvvas declared non-inferior to NPH (FAS: -0.06%, 95% Cl: [-0.21 ; 0.08] % ; PP: -1.5% ; 95% Cl: [-0.34 ; 0.04]%). FPG as significantly lovver ith IDet vs. NPH (table). Hypoglycemia rates ere similar betvveen groups. In summary, lovver FPG, but equivalent HbA1c in late pregnancy ere obtained using insulin detemir in comparison to NPH insulin in vvomen ith T1DM .

detemir; NPH insulin; type 1 diabetes

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