NCT05124457

DETERMINE: Detemir vs NPH

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 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.

Conditions

• Gestational Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin Detemir	Patients are to receive insulin detemir
DRUG	Insulin NPH	Patients are to receive insulin NPH

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-11-18
• Last updated: 2023-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study