NCT05124457

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

October 25, 2021

Last Update Submit

September 25, 2023

Conditions

Gestational DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Neonatal Hypoglycemia

    Rate (%) of neonatal hypoglycemia

    Within the first 24 hours of life

  • Prolonged neonatal hypoglycemia

    Rate (%) of prolonged neonatal hypoglycemia

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

Secondary Outcomes (17)

  • Neonatal Gastrin Level

    At birth

  • Neonatal C-Peptide Level

    At birth

  • Neonatal insulin level

    At birth

  • Neonatal leptin level

    At birth

  • Rates of pregnancy induced hypertension

    1 year

  • +12 more secondary outcomes

Study Arms (2)

Insulin Detemir

EXPERIMENTAL

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

Drug: Insulin Detemir

Insulin NPH

ACTIVE COMPARATOR

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

Drug: Insulin NPH

Interventions

Insulin DetemirDRUG

Patients are to receive insulin detemir

Insulin Detemir
Insulin NPHDRUG

Patients are to receive insulin NPH

Insulin NPH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90069, United States

RECRUITING

Related Publications (11)

  • Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494.

    PMID: 26810997BACKGROUND

  • Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412.

    PMID: 28669379BACKGROUND

  • Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.

    PMID: 22851598BACKGROUND

  • Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015.

    PMID: 32396624BACKGROUND

  • Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.

    PMID: 26070699BACKGROUND

  • Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319.

    PMID: 11924935BACKGROUND

  • O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2.

    PMID: 28156005BACKGROUND

  • Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238.

    PMID: 31498869BACKGROUND

  • Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452.

    PMID: 28637888BACKGROUND

  • Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.

    PMID: 33865836BACKGROUND

  • Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005.

    PMID: 31168280BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin, Isophane

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Christina Han, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Michael Richley, MD

    University of California, Los Angeles

    STUDY DIRECTOR

Central Study Contacts

Michael Richley, MD

CONTACT

310-794-7274mrichley@mednet.ucla.edu

Christina Han, MD

CONTACT

310-794-7274cshan@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to receive either insulin NPH or insulin detemir
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maternal-Fetal Medicine Division Director

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 18, 2021

Study Start

February 1, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)