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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at birth

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Birth Weight

Secondary outcome measures

Apgar Score at Birth

Development of Gestational Diabetes

Maternal Weight Gain in Pregnancy

+17 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gianna WilkieLead Sponsor

1 Previous Clinical Trials

70 Total Patients Enrolled

Gianna L Wilkie, MDPrincipal InvestigatorUMass Memorial Health Care

2 Previous Clinical Trials

250 Total Patients Enrolled

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT04523363 — Phase 4

Prediabetes Research Study Groups: Metformin, Standard of Care

Prediabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04523363 — Phase 4

Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523363 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions typically necessitate Metformin prescription?

"Metformin is an effective remedy for treating exercise, type 1 diabetes mellitus and diabetic ketoacidosis."

Answered by AI

Have there been any other investigations into the efficacy of Metformin?

"At the moment, 170 studies focusing on Metformin are currently in progress. Among these trials, 43 have moved to Phase 3 and most of them take place in Pittsburgh, Pennsylvania; however 1903 clinical sites globally are running investigations into this medication."

Answered by AI

Are there any openings left for participants in this clinical trial?

"At the moment, this trial is not accepting new participants. It was initially posted in January 1st 2023 and last modified on February 1st 2022. If looking for alternative studies, there are 271 investigational studies recruiting patients with prediabetes; during pregnancy and 170 clinical trials involving Metformin which are currently enrolling volunteers."

Answered by AI

What is the current count of participants in this clinical research study?

"No longer accepting participants, this clinical trial was initially posted on January 1st 2023 and its recruitment efforts concluded February 1st 2022. If you are seeking out other opportunities, there are currently 271 open studies regarding prediabetes complications during pregnancy and 170 related to Metformin actively recruiting patients."

Answered by AI

What adverse effects can Metformin have on an individual's health?

"Metformin's safety is highly established, as it has been approved through a Phase 4 trial. Consequently, Power assigned the drug a score of 3 on its rating system."

Answered by AI