Comparing Insulin Detemir and NPH for Managing Diabetes in Pregnancy
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
This study is testing whether insulin detemir or NPH is better for managing blood sugar in pregnant women with diabetes and if it affects the risk of low blood sugar in their newborns.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05124457 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the rates of neonatal hypoglycemia in pregnant women with gestational diabetes or type 2 diabetes who are treated with either insulin detemir or NPH. Insulin detemir is already FDA approved for use in pregnant women with type 1 diabetes, while NPH is the only long-acting insulin approved for type 2 diabetes and gestational diabetes. The study will evaluate the safety and efficacy of these two insulin types in managing blood sugar levels during pregnancy, focusing on the potential risks to newborns. By understanding the differences in hypoglycemia rates between these two treatments, the study seeks to improve maternal and neonatal outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with gestational diabetes or type 2 diabetes who require insulin therapy.
Not a fit: Patients who are not pregnant, have type 1 diabetes, or have contraindications to either insulin type will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer insulin management options for pregnant women with diabetes, reducing the risk of neonatal hypoglycemia.
How similar studies have performed: Previous studies have indicated that insulin detemir may have a lower risk of hypoglycemia compared to NPH, suggesting potential success for this comparative approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Christina Han, MD — University of California, Los Angeles
- Study coordinator: Michael Richley, MD
- Email: mrichley@mednet.ucla.edu
- Phone: 310-794-7274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.