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Anti-diabetic agent

Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

Phase 1

Waitlist Available

Led By Gianna Wilkie, MD

Research Sponsored by University of Massachusetts, Worcester

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

Known diagnosis of pre-existing pre-gestational diabetes in pregnancy

Inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at randomization, 3, 6, and 12 months after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop and test a protocol for screening for diabetes right after childbirth in women who had gestational diabetes during pregnancy. If diabetes is found, the patients will be treated with metformin

Who is the study for?

This trial is for postpartum patients who had gestational diabetes (GDM) and show signs of high blood sugar. They must have been diagnosed with GDM in their third trimester, be able to give consent, speak English or Spanish, and be capable of undergoing glucose testing immediately after delivery at UMASS Memorial.

What is being tested?

The study aims to test a protocol where new mothers who had GDM are screened right after giving birth and then treated with Metformin Hydrochloride if they have high blood sugar levels.

What are the potential side effects?

Metformin may cause side effects such as digestive issues like nausea or diarrhea, potential vitamin B12 deficiency over long-term use, and rarely a serious condition called lactic acidosis.

Eligibility Criteria

Exclusion Criteria

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

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I was diagnosed with diabetes before becoming pregnant.

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I cannot undergo an oral glucose tolerance test due to past surgeries or conditions.

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I am currently taking steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization, 3, 6, and 12 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization, 3, 6, and 12 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization, 3, 6, and 12 months after randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glycemic Outcomes--Fructosamine Levels

Glycemic Outcomes--Hemoglobin A1c

Secondary study objectives

Feasibility of Assessment

Patient Recruitment

Patient Retention

+2 more

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132

35%

Diarrhea

10%

Anemia

10%

Nausea

10%

Gastroesophageal reflux disease

Hepatobiliary disorders

Fall

Weight loss

COVID-19 Infection

Flatulence

Pain

Social circumstances

Vomiting

Headache

Stroke

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Metformin

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Metformin Treatment PostpartumExperimental Treatment1 Intervention

Subjects who are randomly assigned to this condition will be treated with metformin extended-release formulation (500 mg tablet administered orally daily with evening meal) and given the same educational materials given to patients in the comparison condition.

Group II: Standard of Care EducationActive Control1 Intervention

Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin Hydrochloride

2016

Completed Phase 4

~1990

0 / 3Eligibility criteria met