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Recruiting NCT05124457

DETERMINE: Detemir vs NPH

Phase II Interventional Gestational Diabetes Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Insulin Detemir, Insulin NPH.
Who it may be relevant to
Registry conditions: Gestational Diabetes, Diabetes Mellitus, Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Drug Insulin Detemir
    Patients are to receive insulin detemir
  • Drug Insulin NPH
    Patients are to receive insulin NPH

Primary outcome measures

  • Neonatal Hypoglycemia [Time frame: Within the first 24 hours of life]
  • Prolonged neonatal hypoglycemia [Time frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge]
Secondary outcome measures (12)
  • Neonatal Gastrin Level [Time frame: At birth]
  • Neonatal C-Peptide Level [Time frame: At birth]
  • Neonatal insulin level [Time frame: At birth]
  • Neonatal leptin level [Time frame: At birth]
  • Rates of pregnancy induced hypertension [Time frame: 1 year]
  • Mode of delivery [Time frame: At delivery]
  • Gestational Age at delivery [Time frame: At delivery]
  • Maternal glycemic control [Time frame: 1 year]
  • Total daily insulin [Time frame: 1 year]
  • Fetal anomolies [Time frame: At birth]
  • Macrosomia [Time frame: At birth]
  • Polyhydramnios [Time frame: At birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Publications

  • 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 26810997
  • 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 28669379
  • 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 22851598
  • 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 32396624
  • 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 26070699
  • 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 11924935
  • 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 28156005
  • 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 31498869

Identifiers

NCT: NCT05124457 · DETERMINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗