| NCT ID | NCT05124457 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 336 participants in total. It began in 2022-02-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
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
Contact & Investigator
Christina Han, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05124457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05124457 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05124457 currently recruiting?
Yes, NCT05124457 is actively recruiting participants. Contact the research team at mrichley@mednet.ucla.edu for enrollment information.
Where is the NCT05124457 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05124457 clinical trial?
NCT05124457 is sponsored by University of California, Los Angeles. The principal investigator is Christina Han, MD at University of California, Los Angeles. The trial plans to enroll 336 participants.
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