Lifestyle Changes + Metformin for Diabetes Prevention

(DPPOS Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Disqualifiers: Non-DPP participants

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes and the drug metformin (also known as Glucophage, Fortamet, Glumetza, or Riomet) affect long-term health outcomes, such as heart disease and cancer, in individuals at risk of developing diabetes. Researchers focus on how these treatments impact those who showed risk factors for diabetes in earlier studies. Participants will either follow an intensive lifestyle program or take metformin, with some receiving a placebo for comparison. This trial is ideal for individuals who participated in the original Diabetes Prevention Program (DPP). As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes prevention strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both lifestyle changes and metformin are safe options. Studies have found that lifestyle changes, such as improving diet and increasing exercise, can significantly reduce the risk of developing diabetes without major safety concerns. These changes are generally safe and beneficial for most people.

Research has consistently shown metformin to be a safe choice for people at high risk of diabetes. It lowers the chance of developing diabetes by about 31% compared to a placebo. Metformin has been used for many years and is well-tolerated by most people. Some common side effects include mild digestive issues, but these are usually manageable.

Overall, both options have strong safety records, making them promising choices for preventing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of lifestyle changes and Metformin for diabetes prevention because it tackles the condition from both behavioral and pharmacological angles. Metformin is already known for its role in lowering blood sugar, but pairing it with intensive lifestyle interventions could offer a more comprehensive approach to preventing diabetes. The lifestyle component emphasizes personalized guidance on diet and exercise, aiming to instill sustainable habits. This dual approach targets the root causes of diabetes more holistically than medication or lifestyle changes alone, potentially leading to more effective prevention strategies.

What evidence suggests that this trial's treatments could be effective for diabetes prevention?

This trial will compare the effectiveness of lifestyle changes and the medication metformin in preventing diabetes in people at high risk. Research has shown that significant lifestyle changes, such as improving diet and increasing exercise, can reduce the chance of developing diabetes by 58%. Participants in one arm of this trial will focus on these lifestyle changes. Another arm will involve participants taking metformin, a common medication for diabetes, which has been shown to lower the risk by 31%. Both methods have proven effective over long periods, providing lasting benefits. These findings strongly suggest that these strategies can help delay or prevent diabetes in those likely to develop it. ^{1 2 3 5 6}

Who Is on the Research Team?

Barbara Linder, MD, PhD

Principal Investigator

NIDDK Project Scientist

David M Nathan, MD

Principal Investigator

Massachusetts General Hospital

Kishore Gadde, MD

Principal Investigator

Pennington Biomedical Research Center

David Ehrmann, MD

Principal Investigator

University of Chicago

David M. Nathan, MD

Principal Investigator

Massachusetts General Hospital

Medha Munshi, MD

Principal Investigator

Joslin Diabetes Center

Kevin Furlong, MD

Principal Investigator

Jefferson Medical College of Thomas Jefferson University

Samuel Dagogo-Jack, MD, MB

Principal Investigator

University of Tennessee

Marinella Temprosa, PhD

Principal Investigator

George Washington University Biostatistics Center

Mark Molitch, MD

Principal Investigator

Northwestern University

Happy Araneta, PhD,MPH

Principal Investigator

University of California, San Diego

Sherita Hill Golden, MD, MHS

Principal Investigator

Johns Hopkins School of Medicine

David S Schade, MD

Principal Investigator

The University of New Mexico

Santica M Marcovina, PhD

Principal Investigator

University of Washington

Sunder Mudaliar, MD

Principal Investigator

University of California, San Diego

F. Xavier Pi-Sunyer, MD

Principal Investigator

Columbia University

Jill Crandall, MD

Principal Investigator

Albert Einstein College of Medicine

Christine Lee, MD

Principal Investigator

NIDDK Project Scientist

Steven Kahn, MB, ChB

Principal Investigator

University of Washington

Kieren J Mather, MD

Principal Investigator

Indiana University

Michelle Magee, MD

Principal Investigator

Medstar Health Research Institute

Elizabeth Venditti, PhD

Principal Investigator

University of Pittsburgh

Marjerie Mau, MD

Principal Investigator

University of Hawaii

William Knowler, MD

Principal Investigator

SW Indian Center, NIDDK

Karol E Watson, MD

Principal Investigator

University of California, Los Angeles

Angela Brown, MD

Principal Investigator

Washington University School of Medicine

Kathleen Jablonski, PhD

Principal Investigator

George Washington University Biostatistics Center

Ronald B Goldberg, MD

Principal Investigator

University of Miami

Helen P Hazuda, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Dana Dabelea, MD, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for volunteers who were part of the Diabetes Prevention Program, focusing on those at high risk due to impaired glucose tolerance. It's particularly aimed at understanding long-term health outcomes in diverse populations, including a significant minority representation.

Inclusion Criteria

Participation as a volunteer in the Diabetes Prevention Program (DPP)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants were randomized to either intensive lifestyle intervention or metformin treatment during the original DPP trial

6 years

DPPOS Phase 1 and 2

Participants continued with either open-label metformin or lifestyle interventions, with additional group sessions

11 years

DPPOS-3

Long-term follow-up to examine effects of metformin on cardiovascular disease and cancer outcomes

11 years

Annual and mid-year visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• DPPOS Boost Lifestyle
• DPPOS Group Lifestyle
• Intensive Lifestyle Group Session
• Metformin

Trial Overview The study tests the long-term effects of lifestyle interventions and metformin on preventing diabetes. DPPOS-3 specifically looks into how these approaches impact cardiovascular disease and cancer risks as the participant group ages.

How Is the Trial Designed?

Group I: 1 Original Lifestyle Active Control 3 Interventions

randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2

Group II: 2 Original Metformin Active Control 3 Interventions

randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.

Group III: 3 Original Placebo Placebo Group 2 Interventions

randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Indian Health Service (IHS)

Collaborator

Trials

6

Recruited

3,300+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

Office of Research on Women's Health (ORWH)

Collaborator

Trials

34

Recruited

36,300+

Citations

1. repository.niddk.nih.gov repository.niddk.nih.gov/studies/dppos/

Diabetes Prevention Program Outcomes Study (DPPOS) Additional findings after 10 years' follow-up showed that treatment with metformin reduced the rate of developing diabetes by 18%, delayed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00038727

Diabetes Prevention Program Outcomes Study The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

4. dppos.bsc.gwu.edu dppos.bsc.gwu.edu/web/dppos/dppos

What is the Diabetes Prevention Program Outcomes ... - DPPOS By the end of this phase, 87 percent of the surviving DPP cohort joined DPPOS with minimal loss to follow-up among those enrolled in DPPOS. There has been 86-99 ...

5. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(15)00291-0/fulltext

the Diabetes Prevention Program Outcomes Study The results of the DPPOS have shown very long-term effects of lifestyle intervention and metformin to reduce the incidence of diabetes in a ...

6. diabetes.org diabetes.org/newsroom/new-data-from-diabetes-prevention-program-outcomes-study-shows-persistent-reduction-of-t2d-development-over-22-year-average-follow-up

New Data from Diabetes Prevention Program Outcomes ... The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...