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Biguanide

Metformin for Prediabetes in Pregnancy

Phase 4

Waitlist Available

Led By Gianna L Wilkie, MD

Research Sponsored by Gianna Wilkie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Participants who are under the age of 18

Patients already taking metformin for other indications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will test whether metformin can help pregnant women with prediabetes have healthier babies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Metformin may cause side effects such as gastrointestinal issues (nausea, diarrhea), potential vitamin B12 deficiency over long-term use and rarely lactic acidosis - a buildup of lactate in the body which requires immediate medical attention.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am already taking metformin for a health condition.

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I was diagnosed with diabetes in the first trimester of my pregnancy.

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I cannot take metformin due to liver, kidney, or heart issues, or an allergy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Birth Weight

Secondary study objectives

Apgar Score at Birth

Development of Gestational Diabetes

Neonatal Cooling

+10 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MetforminExperimental Treatment1 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 CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 4Eligibility criteria met