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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether taking metformin daily for one year after childbirth can prevent type 2 diabetes in women who had gestational diabetes during pregnancy. Typically, these women are advised to focus on diet and lifestyle changes. The research aims to determine if adding metformin to this routine enhances diabetes prevention. Women who gave birth at Tufts Medical Center, had gestational diabetes, and are willing to take a specific glucose test after delivery might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes prevention strategies.

Will I have to stop taking my current medications?

If you are taking medications that affect glucose metabolism or interfere with metformin, you may need to stop them to participate in the trial. The protocol does not specify a washout period, but you should discuss your current medications with the study team.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin is generally safe and well-tolerated for preventing type 2 diabetes in people at high risk. In past studies, metformin effectively lowered the chance of developing diabetes. Most participants managed the treatment well, with 72% experiencing no major problems.

For those who had gestational diabetes, studies indicate that using metformin does not increase risks such as early birth or birth injuries. This suggests it can be a safe choice for new mothers wanting to lower their risk of diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for preventing type 2 diabetes after gestational diabetes, which often focuses on lifestyle changes and regular monitoring, metformin offers a pharmacological approach. Metformin is unique because it targets insulin resistance, a key player in the development of type 2 diabetes, potentially providing more direct control over blood sugar levels. Researchers are excited about metformin because it could offer a convenient, daily pill that helps prevent the onset of diabetes in women who have had gestational diabetes, potentially reducing long-term health risks.

What evidence suggests that metformin might be an effective treatment for preventing type 2 diabetes after gestational diabetes?

Research has shown that metformin can lower the risk of developing type 2 diabetes, particularly for women who have experienced gestational diabetes. Some studies found that metformin reduced the risk of diabetes by about 50% compared to standard methods like diet and lifestyle changes. This trial will evaluate the effectiveness of metformin, administered daily for 12 months postpartum, in preventing type 2 diabetes. Metformin, a well-known medicine for controlling blood sugar levels, presents a strong option for diabetes prevention. These findings suggest that metformin could play a crucial role in preventing diabetes after pregnancy-related diabetes. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10685917/

Metformin in the prevention of type 2 diabetes after gestational ... In the Diabetes Prevention Programme (DPP) metformin was found to be effective in decreasing the incidence of diabetes. The results of the DPP ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6243218/

Metformin and Type 2 Diabetes Prevention - PMC Metformin significantly reduced the incidence of diabetes by 31% compared to placebo (95% CI 17–43%), whereas lifestyle intervention reduced the incidence by 58 ...

3. academic.oup.com academic.oup.com/jcem/article-abstract/93/12/4774/2627340

Prevention of Diabetes in Women with a History of Gestational ... Among women reporting a history of GDM, both intensive lifestyle and metformin therapy reduced the incidence of diabetes by approximately 50% compared with the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714422003330

A randomized controlled trial of a shared decision making ... Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women ...

5. academic.oup.com academic.oup.com/jcem/article/100/4/1646/2815139

The Diabetes Prevention Program Outcomes Study 10-Year ... In women with a history of GDM, ILS reduced the incidence of diabetes by 53% and metformin reduced the incidence by 50%. In women without GDM, ILS had a similar ...

6. diabetesjournals.org diabetesjournals.org/care/article/47/9/1688/157019/Perinatal-Outcomes-Associated-With-Metformin-Use

Perinatal Outcomes Associated With Metformin Use During ... The primary outcome was a composite of preterm birth, birth injury, neonatal respiratory distress, neonatal hypoglycemia, and neonatal ...

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16361

A narrative review of metformin in pregnancy: Navigating ... The results are mostly disappointing. They suggest that metformin does not stop gestational diabetes from developing. However, the participants ...

8. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07869-6

Metformin use in gestational diabetes is not associated with ... Treatment with metformin was not associated with an increased risk of adverse outcomes, including small for gestational age and preterm labor in women with GDM.