DETERMINE: Detemir vs NPH
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (1)
CA
- University of California, Los Angeles · Los Angeles, CA 90069Christina S Han, MD · Study contact · cshan@mednet.ucla.eduMichael A Richley, MD · Study contact · mrichley@mednet.ucla.eduMore trials in Los Angeles