DETERMINE: Detemir vs NPH (DETERMINE)

A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

Inclusion Criteria: Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy. Exclusion Criteria: Multiple Gestation Type 1 Diabetes mellatus Age < 18 Known or suspected hypersensitivity to NPH or insulin detemir Known fetal major malformations Chronic renal or hepatic insufficiency Known to be HIV, Hepatitis B, or Hepatitis C positive Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery) Insulin dependent before conception

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