A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Who is this study for? Pregnant Women
What treatments are being studied? Insulin Detemir
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Michael Richley, MD
mrichley@mednet.ucla.edu
310-794-7274
Backup
Christina Han, MD
cshan@mednet.ucla.edu
310-794-7274
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 336
Treatments
Experimental: Insulin Detemir
Patients are to receive insulin detemir as long acting insulin to control blood sugars
Active_comparator: Insulin NPH
Patients are to receive insulin NPH as long acting insulin to control blood sugars
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles