DETERMINE: Detemir vs NPH
Recruiting · NCT05124457 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
Insulin DetemirInsulin NPH
What this trial is about
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- 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
Where it is running
1 location listed across 1 US state.
- University of California, Los Angeles - Los Angeles, California, United States