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DETERMINE: Detemir vs NPH
RecruitingPhase 2
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
What is being tested
- Insulin Detemir (drug)
- Insulin NPH (drug)
Sponsor: University of California, Los Angeles · Participants: 336 · Started: Feb 1, 2022
Contact the study team
- Michael Richley, MD · Phone: 310-794-7274
- Christina Han, MD · Phone: 310-794-7274
Official record on ClinicalTrials.gov — NCT05124457
Locations in the U.S.
| California | University of California, Los Angeles, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.