DETERMINE: Detemir vs NPH

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

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