DETERMINE: Detemir vs NPH
About the study
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
Exclusion Criteria:
- Multiple Gestation
- Type 1 Diabetes mellatus
- Age < 18
- Known or suspected hypersensitivity to NPH or insulin detemir
- Known fetal major malformations
- Chronic renal or hepatic insufficiency
- Known to be HIV, Hepatitis B, or Hepatitis C positive
- Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
- Insulin dependent before conception
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Gestational Diabetes,Diabetes Mellitus, Type 2
Age
18+
Phase
PHASE2
Participants Needed
336
Est. Completion Date
Jun 30, 2025
Treatment Type
INTERVENTIONAL
Sponsor
University of California, Los Angeles
ClinicalTrials.gov NCT Identifier
NCT05124457
Study Number
DETERMINE
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