DETERMINE: Detemir vs NPH

Last updated: September 25, 2023
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes (Pediatric)

Treatment

Insulin NPH

Insulin Detemir

Clinical Study ID

NCT05124457
DETERMINE
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 classicalcesarean delivery)
  9. Insulin dependent before conception

Study Design

Total Participants: 336
Treatment Group(s): 2
Primary Treatment: Insulin NPH
Phase: 2
Study Start date:
February 01, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • University of California, Los Angeles

    Los Angeles, California 90069
    United States

    Active - Recruiting

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