NCT05124457RecruitingPhase 2
DETERMINE: Detemir vs NPH
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Source: ClinicalTrials.gov · Last updated 26 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- First submitted
- 25 Oct 2021
- Start date
- 1 Feb 2022
- Primary completion date
- Jun 2025
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Type 2 diabetes
- NCT number
- NCT05124457
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 336
- From 1 Feb 2022 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
Other illness
- Type 1 Diabetes mellatus
- Known or suspected hypersensitivity to NPH or insulin detemir
- Chronic renal or hepatic insufficiency
- Known to be HIV, Hepatitis B, or Hepatitis C positive
Age
- Age \< 18
Other
- Multiple Gestation
- Known fetal major malformations
- Insulin dependent before conception
Who the study is looking for
- Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.