Metformin for Prediabetes in Pregnancy

Overseen By Heidi Leftwich, DO

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Gianna Wilkie

Must not be taking: Metformin

Disqualifiers: Diabetes, Liver failure, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gianna L Wilkie, MD

Principal Investigator

UMass Memorial Health

Eligibility Criteria

This trial is for pregnant women receiving care at UMass Memorial Medical Center, who have prediabetes indicated by specific blood sugar tests before the 14th week of gestation. They must be able to consent in writing. It's not for those under 18, with pre-existing diabetes, on metformin already, or if they have liver/renal/heart failure, sensitivity to metformin, a multiple pregnancy or noted fetal defects.

Inclusion Criteria

You received pregnancy and delivery care at University of Massachusetts (UMass) Memorial Medical Center.

Patients able to provide written informed consent

Pregnant women with early signs of high blood sugar levels.

Exclusion Criteria

I am under 18 years old.

I am already taking metformin for a health condition.

You have experienced a miscarriage before being selected for the study.

Treatment Details

Interventions

• Metformin

Trial Overview The study is testing whether metformin can reduce the risk of having large babies among pregnant women with prediabetes compared to standard treatment without metformin. The goal is to see if this drug can improve outcomes for these pregnancies.

Participant Groups

Group I: Metformin Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Gianna Wilkie

Lead Sponsor

Trials

2

Recruited

310+