Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Christina Han, MD (ucla)

Description

Summary

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

Official Title

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

Details

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.

Keywords

Gestational Diabetes Diabetes Mellitus, Type 2 Diabetes, Gestational Diabetes Mellitus Insulin Insulin, Globin Zinc Insulin Detemir Isophane Insulin, Human Insulin, Isophane Isophane insulin, beef Insulin NPH

Eligibility

You can join if…

Open to people ages 18 years and up

  • Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.

You CAN'T join if...

  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

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90069 United States

Lead Scientist at University of California Health

  • Christina Han, MD (ucla)
    Associate Professor of Clinical, Obstetrics and Gynecology, Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Abstract Abstract #2
ID
NCT05124457
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 336 study participants
Last Updated