DETERMINE: Detemir vs NPH

NCT ID: NCT05124457

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Gestational Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Detemir

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

Group Type: EXPERIMENTAL

Insulin Detemir

Intervention Type: DRUG

Patients are to receive insulin detemir

Insulin NPH

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

Group Type: ACTIVE_COMPARATOR

Insulin NPH

Intervention Type: DRUG

Patients are to receive insulin NPH

Interventions

Insulin Detemir

Patients are to receive insulin detemir

Intervention Type: DRUG

Insulin NPH

Patients are to receive insulin NPH

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Christina S. Han

Maternal-Fetal Medicine Division Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Han, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Michael Richley, MD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Richley, MD

Role: CONTACT

mrichley@mednet.ucla.edu

310-794-7274

Christina Han, MD

Role: CONTACT

cshan@mednet.ucla.edu

310-794-7274

Facility Contacts

Christina S Han, MD

Role: primary

cshan@mednet.ucla.edu

Michael A Richley, MD

Role: backup

mrichley@mednet.ucla.edu

References

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.

Reference Type: BACKGROUND

PMID: 26810997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28669379 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22851598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32396624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26070699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11924935 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28156005 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31498869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28637888 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 31168280 (View on PubMed)

Related Links

https://doi.org/10.1016/j.ajog.2019.11.450

Abstract

https://doi.org/10.1016/j.ajog.2019.11.057

Abstract

Other Identifiers

DETERMINE

Identifier Type: -

Identifier Source: org_study_id