DETERMINE: Detemir vs NPH

Sponsor
University of California, Los Angeles (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05124457
Collaborator
(none)
336
Enrollment
2
Arms
43
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Insulin Detemir
  • Drug: Insulin NPH
Phase 2

Detailed Description

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization to receive either insulin NPH or insulin detemirRandomization to receive either insulin NPH or insulin detemir
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Insulin Detemir

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

Drug: Insulin Detemir
Patients are to receive insulin detemir

Active Comparator: Insulin NPH

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

Drug: Insulin NPH
Patients are to receive insulin NPH

Outcome Measures

Primary Outcome Measures

  1. Neonatal Hypoglycemia [Within the first 24 hours of life]

    Rate (%) of neonatal hypoglycemia

  2. Prolonged neonatal hypoglycemia [Neonatal hypoglycemia after the 1st 24 hours of life but before discharge]

    Rate (%) of prolonged neonatal hypoglycemia

Secondary Outcome Measures

  1. Neonatal Gastrin Level [At birth]

    Sample form cord blood

  2. Neonatal C-Peptide Level [At birth]

    Sample from cord blood

  3. Neonatal insulin level [At birth]

    Sample from cord blood

  4. Neonatal leptin level [At birth]

    Sample from cord blood

  5. Rates of pregnancy induced hypertension [1 year]

    Maternal rates of preeclampsia, eclampsia, or gestational hypertension

  6. Mode of delivery [At delivery]

    Spontaneous vaginal, operative vaginal, cesarean

  7. Gestational Age at delivery [At delivery]

    Gestational Age at delivery

  8. Maternal glycemic control [1 year]

    Rate (%) of in range maternal blood glucose control in antepartum period

  9. Total daily insulin [1 year]

    Total daily insulin dose in patient

  10. Fetal anomolies [At birth]

    Rate (%) of fetal anomolies

  11. Macrosomia [At birth]

    Rate (%) of macrosomia

  12. Polyhydramnios [At birth]

    Rate (%) of polyhydramnios

  13. Neonatal weight [At birth]

    Neonatal weight

  14. Need for supplemental oxygen [1 year]

    Rate of supplemental oxygen use (%) in neonate

  15. Need for dextrose infusion in neonate [1 year]

    Rate of dextrose infusion use (%) in neonate

  16. Rates of respiratory distress syndrome [1 year]

    Rate of RDS (%) in neonate

  17. 5 Minute APGAR [At birth]

    5 Minute APGAR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

  • Principal Investigator: Christina Han, MD, University of California, Los Angeles
  • Study Director: Michael Richley, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Christina S. Han, Maternal-Fetal Medicine Division Director, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT05124457
Other Study ID Numbers:
  • DETERMINE
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021