DETERMINE: Detemir vs NPH

Recruiting now · Phase 2

Conditions studied: Gestational Diabetes, Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT05124457

Run by

University of California, Los Angeles

People needed

336

Starts

2022-02-01

Expected to finish

2025-06-01

Last updated by the study team

2023-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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