RCT Glargine vs NPH for Treatment of DM in Pregnancy

NCT06619301 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 217918
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Conditions

Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus (T2DM); Gestational Diabetes Mellitus, Class A2

Keywords

Glargine; NPH; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia

  Episodes of hypoglycemia with blood glucose less than 60 mg/dL

  From initiation of insulin therapy to delivery

Secondary Outcomes (2)

• Large for Gestational Age

  At delivery

• Shoulder dystocia

  At delivery

Study Arms (2)

Insulin Glargine

ACTIVE COMPARATOR

Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Drug: Insulin glargine

Insulin NPH

ACTIVE COMPARATOR

Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Drug: insulin NPH

Interventions

Insulin glargine DRUG

Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.

Also known as: Lantus, Toujeo, Basaglar, Semglee

Insulin Glargine

insulin NPH DRUG

Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Also known as: Novolin, Humulin

Insulin NPH

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
• At least 18 years old
• Insulin started prior to 34 weeks gestation
• Established prenatal care by 14 weeks gestation

You may not qualify if:

• Those under the age of 18 years old
• Those unable to consent in english
• Allergy to insulin
• Controlled with only diet modification or the use of oral antihyperglycemics
• Has diagnosis of Type 1 Diabetes Mellitus
• Receiving insulin through an insulin pump

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (13)

• Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.

  PMID: 15855602 BACKGROUND

• Smith JG, Manuck TA, White J, Merrill DC. Insulin glargine versus neutral protamine Hagedorn insulin for treatment of diabetes in pregnancy. Am J Perinatol. 2009 Jan;26(1):57-62. doi: 10.1055/s-0028-1095181. Epub 2008 Oct 31.

  PMID: 18979406 BACKGROUND

• Negrato CA, Rafacho A, Negrato G, Teixeira MF, Araujo CA, Vieira L, Silva CA, Date SK, Demarchi AC, Gomes MB. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study. Diabetes Res Clin Pract. 2010 Jul;89(1):46-51. doi: 10.1016/j.diabres.2010.03.015. Epub 2010 Apr 7.

  PMID: 20378197 BACKGROUND

• Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet. 2015 Oct;292(4):749-56. doi: 10.1007/s00404-015-3692-3. Epub 2015 Apr 9.

  PMID: 25855052 BACKGROUND

• Fang YM, MacKeen D, Egan JF, Zelop CM. Insulin glargine compared with Neutral Protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009 Mar;22(3):249-53. doi: 10.1080/14767050802638170.

  PMID: 19330710 BACKGROUND

• Egerman RS, Ramsey RD, Kao LW, Bringman JJ, Haerian H, Kao JL, Bush AJ. Perinatal outcomes in pregnancies managed with antenatal insulin glargine. Am J Perinatol. 2009 Sep;26(8):591-5. doi: 10.1055/s-0029-1220782. Epub 2009 Apr 15.

  PMID: 19370512 BACKGROUND

• Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 2007 Apr;114(4):453-7. doi: 10.1111/j.1471-0528.2006.01216.x. Epub 2007 Jan 25.

  PMID: 17261126 BACKGROUND

• 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: 33865836 BACKGROUND

• 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 BACKGROUND

• Barnett AH. A review of basal insulins. Diabet Med. 2003 Nov;20(11):873-85. doi: 10.1046/j.1464-5491.2003.00996.x.

  PMID: 14632712 BACKGROUND

• Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.

  PMID: 15647580 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.

  PMID: 30461693 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

Insulin Glargine; Insulin, Isophane; Insulin; Insulin, Regular, Human

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Joana Lopes Perdigao, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joana Lopes Perdigao, MD

CONTACT

708-216-4033; joana.perdigao@lumc.edu

Nuong Truong, MD

CONTACT

708-216-4033; nuong.t.truong@luhs.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not documented in the patient\'s electronic medical record if they are in the study and were randomized or if they declined randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each patient will continue management of diabetes mellitus in pregnancy with whichever medication they randomize to, Glargine or NPH. Analysis will be intention-to-treat.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)