A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
University of California, Los Angeles
Summary
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Description
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 o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: 1. Multiple Gestation 2. Type 1 Diabetes mellatus 3. Age \< 18 4. Known or suspected hypersensitivity to NPH or insulin detemir 5. Known fetal major malformations 6. Chronic renal or hepatic insufficiency 7. Known to be HIV, Hepatitis B, or Hepatitis C positive 8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery) 9. Insulin dependent before conception
Interventions
- DrugInsulin Detemir
Patients are to receive insulin detemir
- DrugInsulin NPH
Patients are to receive insulin NPH
Location
- University of California, Los AngelesLos Angeles, California