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DETERMINE: Detemir vs NPH

About

Brief Summary

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
21-001917
Category
Endocrine and Metabolic Disorders
Pediatric and Prenatal Disorders
Contact
Michael Richley
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05124457
For detailed technical eligibility, visit ClinicalTrials.gov.