Recruiting
DETERMINE: Detemir vs NPH
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
ClinicalTrials.gov IDNCT05124457
PhasePHASE2
Enrollment336
SponsorUniversity of California, Los Angeles
Age18 Years
SexALL
Conditions studied
Gestational Diabetes, Diabetes Mellitus, Type 2
About this study
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Interventions
- Drug: Insulin Detemir — Patients are to receive insulin detemir
- Drug: Insulin NPH — Patients are to receive insulin NPH
Primary outcomes
- Neonatal Hypoglycemia (Within the first 24 hours of life)
- Prolonged neonatal hypoglycemia (Neonatal hypoglycemia after the 1st 24 hours of life but before discharge)
Eligibility information
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
Study locations
- University of California, Los Angeles, Los Angeles, California 90069 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.