DETERMINE: Detemir vs NPH

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05124457
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Insulin Detemir — DRUG
    Patients are to receive insulin detemir
  • Insulin NPH — DRUG
    Patients are to receive insulin NPH

Study Details

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

Key Dates

Start date
Feb 1, 2022
Status verified
Sep 2023
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Neonatal Hypoglycemia [ Time Frame: Within the first 24 hours of life ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90069
Christina S Han, MD
Michael A Richley, MD

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