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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05124457
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : September 26, 2023
Information provided by (Responsible Party):
Christina S. Han, University of California, Los Angeles

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Diabetes Mellitus, Type 2 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization 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
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05124457

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Contact: Michael Richley, MD 310-794-7274
Contact: Christina Han, MD 310-794-7274

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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90069
Contact: Christina S Han, MD   
Contact: Michael A Richley, MD   
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Christina Han, MD University of California, Los Angeles
Study Director: Michael Richley, MD University of California, Los Angeles
Additional Information:

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Responsible Party: Christina S. Han, Maternal-Fetal Medicine Division Director, University of California, Los Angeles Identifier: NCT05124457    
Other Study ID Numbers: DETERMINE
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Insulin, Globin Zinc
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs