DETERMINE: Detemir vs NPH

NCT05124457 · University of California, Los Angeles

Recruiting

In plain English

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Official title

A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study

About this study

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

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

Study design

Enrollment target: 336 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2022-02-01

Estimated completion: 2025-06

Last updated: 2023-09-26

Interventions

Drug: Insulin DetemirDrug: Insulin NPH

Primary outcomes

• Neonatal Hypoglycemia (Within the first 24 hours of life)
• Prolonged neonatal hypoglycemia (Neonatal hypoglycemia after the 1st 24 hours of life but before discharge)

Sponsor

University of California, Los Angeles · other

Contacts & investigators

ContactMichael Richley, MD · contact · mrichley@mednet.ucla.edu · 310-794-7274

ContactChristina Han, MD · contact · cshan@mednet.ucla.edu · 310-794-7274

InvestigatorChristina Han, MD · principal_investigator, University of California, Los Angeles

InvestigatorMichael Richley, MD · study_director, University of California, Los Angeles

All locations (1)

University of California, Los AngelesRecruiting

Los Angeles, California, United States

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