Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

NCT04523363 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: H00021261
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Conditions

Prediabetes; Complicating Pregnancy

Keywords

maternal outcomes; neonatal outcomes; metformin; prediabetes; pregnancy

Outcome Measures

Primary Outcomes (1)

• Birth Weight

  Used to determine large for gestational age status

  At Birth

Secondary Outcomes (20)

• Number of Participants needing Cesarean Section

  At Delivery

• Number of Participants with Postpartum Hemorrhage

  At Delivery

• Number of Participants with Development of Pregnancy Induced Hypertension

  Through study completion, starting at 14 weeks until delivery

• Development of Gestational Diabetes

  Assessed at 28 weeks of pregnancy

• Maternal Weight Gain in Pregnancy

  At enrollment and last prenatal visit, starting at 14 weeks until delivery

Study Arms (2)

Metformin

EXPERIMENTAL

Study subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.

Drug: Metformin

Standard of Care

NO INTERVENTION

Study subjects will be randomized to standard of care and receive routine prenatal care without further intervention for their prediabetes.

Interventions

Metformin DRUG

Maximum dosage of 500 mg tablets 2 times a day (with each meal)

Also known as: Glucophage

Metformin

Eligibility Criteria

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

You may qualify if:

• Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
• Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
• Patients able to provide written informed consent

You may not qualify if:

• Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
• Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
• Participants who are under the age of 18
• Multiple Pregnancy
• Patients already taking metformin for other indications
• Fetal defect noted on early dating ultrasound
• Miscarriage before randomization

Sponsors & Collaborators

• Gianna Wilkie: lead

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

• Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.

  PMID: 25439811 BACKGROUND

• Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care. 2008 May;31(5):899-904. doi: 10.2337/dc07-2345. Epub 2008 Jan 25.

  PMID: 18223030 BACKGROUND

• Temple R, Murphy H. Type 2 diabetes in pregnancy - An increasing problem. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):591-603. doi: 10.1016/j.beem.2010.05.011.

  PMID: 20832738 BACKGROUND

• Lee AM, Fermin CR, Filipp SL, Gurka MJ, DeBoer MD. Examining trends in prediabetes and its relationship with the metabolic syndrome in US adolescents, 1999-2014. Acta Diabetol. 2017 Apr;54(4):373-381. doi: 10.1007/s00592-016-0958-6. Epub 2017 Jan 9.

  PMID: 28070750 BACKGROUND

• Chen L, Pocobelli G, Yu O, Shortreed SM, Osmundson SS, Fuller S, Wartko PD, Mcculloch D, Warwick S, Newton KM, Dublin S. Early Pregnancy Hemoglobin A1C and Pregnancy Outcomes: A Population-Based Study. Am J Perinatol. 2019 Aug;36(10):1045-1053. doi: 10.1055/s-0038-1675619. Epub 2018 Nov 30.

  PMID: 30500961 BACKGROUND

• Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.

  PMID: 26696673 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Pregnancy Complications

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Gianna L Wilkie, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, single center, randomized study evaluating metformin in the treatment of pregnant women with prediabetes on maternal and neonatal outcomes.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)