Insulin Detemir Safe to Use in Pregnant Women with Type 1 Diabetes
Dr. Elisabeth R. Mathiesen from the University of Copenhagen, Denmark stated that, "Based on this study, the FDA in the USA finds it safe to use insulin detemir in pregnancy."...
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"In our center in Copenhagen the majority of women with type 1 diabetes now use insulin detemir or an insulin pump in pregnancy."
"The main importance of the study is that women already on insulin detemir prior to pregnancy do not need to change to NPH insulin in early pregnancy," Dr. Mathiesen said.
"Perinatal outcome is similar in the two groups, and a paper dealing with these data will be submitted soon," she added.
Dr. Mathiesen and colleagues in the Detemir in Pregnancy Study Group compared glycemic control (hemoglobin A1c at 36 weeks gestation) in 310 pregnant women with type 1 diabetes treated with either insulin detemir or NPH insulin.
The estimated mean A1c was 6.27% for detemir and 6.33% for NPH. The difference was not statistically significant.
The treatment goal of A1c of 6.0% or lower was achieved by 41% of women taking detemir and 32% of women taking NPH (P=0.280).
Estimated mean fasting plasma glucose was significantly lower with detemir than with NPH at both 24 and 36 gestational weeks, but this did not translate into significant differences between the groups in hypoglycemic episodes.
Rates of adverse events during pregnancy were also similar in the two treatment groups.
Mean doses of basal insulin were similar in the two treatment groups, as was mean weight gain during pregnancy (11.5 kg with insulin detemir and 11.0 kg with NPH insulin).
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