Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3155
Source ID: NCT05124457
Associated Drug: Insulin Detemir
Title: DETERMINE: Detemir vs NPH
Acronym: DETERMINE
Status: RECRUITING
Study Results: NO
Results:
Conditions: Gestational Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Detemir|DRUG: Insulin NPH
Outcome Measures: Primary: Neonatal Hypoglycemia, Rate (%) of neonatal hypoglycemia, Within the first 24 hours of life|Prolonged neonatal hypoglycemia, Rate (%) of prolonged neonatal hypoglycemia, Neonatal hypoglycemia after the 1st 24 hours of life but before discharge | Secondary: Neonatal Gastrin Level, Sample form cord blood, At birth|Neonatal C-Peptide Level, Sample from cord blood, At birth|Neonatal insulin level, Sample from cord blood, At birth|Neonatal leptin level, Sample from cord blood, At birth|Rates of pregnancy induced hypertension, Maternal rates of preeclampsia, eclampsia, or gestational hypertension, 1 year|Mode of delivery, Spontaneous vaginal, operative vaginal, cesarean, At delivery|Gestational Age at delivery, Gestational Age at delivery, At delivery|Maternal glycemic control, Rate (%) of in range maternal blood glucose control in antepartum period, 1 year|Total daily insulin, Total daily insulin dose in patient, 1 year|Fetal anomolies, Rate (%) of fetal anomolies, At birth|Macrosomia, Rate (%) of macrosomia, At birth|Polyhydramnios, Rate (%) of polyhydramnios, At birth|Neonatal weight, Neonatal weight, At birth|Need for supplemental oxygen, Rate of supplemental oxygen use (%) in neonate, 1 year|Need for dextrose infusion in neonate, Rate of dextrose infusion use (%) in neonate, 1 year|Rates of respiratory distress syndrome, Rate of RDS (%) in neonate, 1 year|5 Minute APGAR, 5 Minute APGAR, At birth
Sponsor/Collaborators: Sponsor: University of California, Los Angeles
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 336
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2025-06
Results First Posted:
Last Update Posted: 2023-09-26
Locations: University of California, Los Angeles, Los Angeles, California, 90069, United States
URL: https://clinicaltrials.gov/show/NCT05124457