2779 Participants Needed

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)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). 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 take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Who Is on the Research Team?

DM

David M Nathan, MD

Principal Investigator

Massachusetts General Hospital

MM

Medha Munshi, MD

Principal Investigator

Joslin Diabetes Center

DM

David M. Nathan, MD

Principal Investigator

Massachusetts General Hospital

BL

Barbara Linder, MD, PhD

Principal Investigator

NIDDK Project Scientist

KG

Kishore Gadde, MD

Principal Investigator

Pennington Biomedical Research Center

DE

David Ehrmann, MD

Principal Investigator

University of Chicago

KF

Kevin Furlong, MD

Principal Investigator

Jefferson Medical College of Thomas Jefferson University

SD

Samuel Dagogo-Jack, MD, MB

Principal Investigator

University of Tennessee

MT

Marinella Temprosa, PhD

Principal Investigator

George Washington University Biostatistics Center

MM

Mark Molitch, MD

Principal Investigator

Northwestern University

HA

Happy Araneta, PhD,MPH

Principal Investigator

University of California, San Diego

SH

Sherita Hill Golden, MD, MHS

Principal Investigator

Johns Hopkins School of Medicine

DS

David S Schade, MD

Principal Investigator

The University of New Mexico

SM

Santica M Marcovina, PhD

Principal Investigator

University of Washington

SM

Sunder Mudaliar, MD

Principal Investigator

University of California, San Diego

FX

F. Xavier Pi-Sunyer, MD

Principal Investigator

Columbia University

JC

Jill Crandall, MD

Principal Investigator

Albert Einstein College of Medicine

CL

Christine Lee, MD

Principal Investigator

NIDDK Project Scientist

SK

Steven Kahn, MB, ChB

Principal Investigator

University of Washington

KJ

Kieren J Mather, MD

Principal Investigator

Indiana University

MM

Michelle Magee, MD

Principal Investigator

Medstar Health Research Institute

EV

Elizabeth Venditti, PhD

Principal Investigator

University of Pittsburgh

MM

Marjerie Mau, MD

Principal Investigator

University of Hawaii

WK

William Knowler, MD

Principal Investigator

SW Indian Center, NIDDK

KE

Karol E Watson, MD

Principal Investigator

University of California, Los Angeles

AB

Angela Brown, MD

Principal Investigator

Washington University School of Medicine

KJ

Kathleen Jablonski, PhD

Principal Investigator

George Washington University Biostatistics Center

RB

Ronald B Goldberg, MD

Principal Investigator

University of Miami

HP

Helen P Hazuda, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

DD

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?
3Treatment groups
Active Control
Placebo Group
Group I: 1 Original LifestyleActive Control3 Interventions
Group II: 2 Original MetforminActive Control3 Interventions
Group III: 3 Original PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

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+
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