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Biguanide

Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

Phase 3

Waitlist Available

Led By Erika Werner, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

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

Must have

≥18 years of age

Be older than 18 years old

Must not have

Congestive heart failure(CHF)

Preexisting diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether the diabetes drug metformin can also help prevent the disease in women who have had gestational diabetes.

Who is the study for?

This trial is for women over 18 who had gestational diabetes and are delivering at Tufts Medical Center. They must have opted for a specific glucose test postpartum and be able to consent. Women already on metformin, with liver disease, heart failure, or other conditions affecting glucose metabolism can't join.

What is being tested?

The study tests if taking metformin daily for a year after giving birth helps prevent type 2 diabetes in those who had gestational diabetes, compared to the usual diet and lifestyle advice.

What are the potential side effects?

Metformin may cause side effects like nausea, diarrhea, stomach pain, or loss of appetite. It's generally well-tolerated but can rarely lead to vitamin B12 deficiency or affect kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

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

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I have been diagnosed with congestive heart failure.

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I have diabetes.

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I am not on medication that affects metformin breakdown.

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I am currently taking metformin and I am not pregnant.

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I cannot take metformin due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

HbA1C

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

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: MetforminExperimental Treatment1 Intervention

Participants will be given a daily prescription of metformin for 12 months postpartum. At 12 months and again at 15 months (3 months off the drug), HbA1c and weight will be assessed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 6Eligibility criteria met