Recruiting
Phase 2

Detemir vs NPH

Sponsor:

UCLA

Code:

NCT05124457

Conditions

Gestational Diabetes

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insulin Detemir

Insulin NPH

Study Details

Brief summary:

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

Study ID

NCT05124457

Start date

Feb 1, 2022

Status verified date

Sep, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

336 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Insulin Detemir

Patients are to receive insulin detemir as long acting insulin to control blood sugars

active comparator: Insulin NPH

Patients are to receive insulin NPH as long acting insulin to control blood sugars

Interventions

Insulin Detemir

Patients are to receive insulin detemir

Insulin NPH

Patients are to receive insulin NPH

Primary outcome measure

  • Neonatal Hypoglycemia [ Time Frame: Within the first 24 hours of life ]
  • Prolonged neonatal hypoglycemia [ Time Frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge ]

Central Contacts and Locations

Central contacts

Michael Richley, MD

310-794-7274mrichley@mednet.ucla.edu

Christina Han, MD

310-794-7274cshan@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90069

Contacts

Christina S Han, MD

cshan@mednet.ucla.edu

Michael A Richley, MD

mrichley@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 26, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2023-09-26.