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

NCT05124457 Phase 2 RECRUITING

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

Details

Lead sponsor	University of California, Los Angeles
Phase	Phase 2
Status	RECRUITING
Enrolment	336
Start date	2022-02-01
Completion	2025-06

Conditions

• Gestational Diabetes
• Diabetes Mellitus, Type 2

Interventions

• Insulin Detemir
• Insulin NPH

Primary outcomes

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

Countries

United States