DETERMINE: Detemir vs NPH

Description

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

Conditions

Gestational Diabetes, Diabetes Mellitus, Type 2

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Study Overview

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Study Details

Study overview

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

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

DETERMINE: Detemir vs NPH

Condition
Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Christina Han, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Michael Richley, MD, STUDY_DIRECTOR, University of California, Los Angeles

Study Record Dates

2025-06