Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

Overseen By Jennifer Ludgin, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Tufts Medical Center

Must not be taking: Metformin, Steroids, others

Disqualifiers: Liver disease, Renal impairment, CHF, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: 16

Duration: 12 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.

Who Is on the Research Team?

Erika Werner, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to sign the informed consent

Chose to have the 2-hour 75-gram oral glucose tolerance test (OGTT) while in the hospital after giving birth.

Women currently pregnant with planned delivery at Tufts Medical Center

Exclusion Criteria

I have been diagnosed with congestive heart failure.

Decided against the 2 hour 75 gram OGTT during postpartum hospitalization

I have diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 days postpartum

1 visit (in-person)

Treatment

Participants receive a daily prescription of metformin for 12 months postpartum

12 months

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HbA1c and weight assessment

3 months

Final study visit at 15 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview 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.

How Is the Trial Designed?

Group I: Metformin Experimental Treatment 1 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.

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?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+