Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05124457

DETERMINE: Detemir vs NPH

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Los Angeles

Los Angeles, California, 90069, United States

Location status: Recruiting

Location contact

Christina S Han, MD

CONTACT

[email protected]

Michael A Richley, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Multiple Gestation
  • Type 1 Diabetes mellatus
  • Age < 18
  • Known or suspected hypersensitivity to NPH or insulin detemir
  • Known fetal major malformations
  • Chronic renal or hepatic insufficiency
  • Known to be HIV, Hepatitis B, or Hepatitis C positive
  • Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
  • Insulin dependent before conception

Treatment and study plan

insulin detemir

Drug

Patients are to receive insulin detemir

insulin NPH

Drug

Patients are to receive insulin NPH

Primary outcomes

  1. Neonatal Hypoglycemia

    Time frame: Within the first 24 hours of life

    Rate (%) of neonatal hypoglycemia

  2. Prolonged neonatal hypoglycemia

    Time frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge

    Rate (%) of prolonged neonatal hypoglycemia

Secondary outcomes

  1. Neonatal Gastrin Level

    Time frame: At birth

    Sample form cord blood

  2. Neonatal C-Peptide Level

    Time frame: At birth

    Sample from cord blood

  3. Neonatal insulin level

    Time frame: At birth

    Sample from cord blood

  4. Neonatal leptin level

    Time frame: At birth

    Sample from cord blood

  5. Rates of pregnancy induced hypertension

    Time frame: 1 year

    Maternal rates of preeclampsia, eclampsia, or gestational hypertension

  6. Mode of delivery

    Time frame: At delivery

    Spontaneous vaginal, operative vaginal, cesarean

  7. Gestational Age at delivery

    Time frame: At delivery

    Gestational Age at delivery

  8. Maternal glycemic control

    Time frame: 1 year

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

  9. Total daily insulin

    Time frame: 1 year

    Total daily insulin dose in patient

  10. Fetal anomolies

    Time frame: At birth

    Rate (%) of fetal anomolies

  11. Macrosomia

    Time frame: At birth

    Rate (%) of macrosomia

  12. Polyhydramnios

    Time frame: At birth

    Rate (%) of polyhydramnios

  13. Neonatal weight

    Time frame: At birth

    Neonatal weight

  14. Need for supplemental oxygen

    Time frame: 1 year

    Rate of supplemental oxygen use (%) in neonate

  15. Need for dextrose infusion in neonate

    Time frame: 1 year

    Rate of dextrose infusion use (%) in neonate

  16. Rates of respiratory distress syndrome

    Time frame: 1 year

    Rate of RDS (%) in neonate

  17. 5 Minute APGAR

    Time frame: At birth

    5 Minute APGAR

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Han, MD

CONTACT

[email protected]

310-794-7274

Michael Richley, MD

CONTACT

[email protected]

310-794-7274

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: DETERMINE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2021
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.