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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California, Los Angeles
Los Angeles, California, United States
Start Date
February 1, 2022
Primary Completion Date
June 1, 2025
Completion Date
June 1, 2025
Last Updated
September 26, 2023
336
ESTIMATED participants
Insulin Detemir
DRUG
Insulin NPH
DRUG
Lead Sponsor
University of California, Los Angeles
NCT06959901
NCT06574035
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06861062