Diabetes Prevention Program Outcomes Study

Study acronym: DPPOS
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Notable Primary endpoints revised (4)v13 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Oct 2024 to Feb 28, 2020
    • Study completion date changed from estimate of Jan 2025 to Apr 30, 2022
    • Start date: Sep 2002 to Jul 31, 1996
    • Secondary endpoints: details revised at 4 of 5 entries
  2. Re-verified, no change to tracked fieldsv12
  3. Minor Secondary endpoints: 4 to 5v11
  4. Minor Secondary endpoints: details revised at 4 of 4 entriesv10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary endpoints revised (4)v8 Show 4 more changesShow less
    • Secondary endpoints revised (4)
    • Study description revised
    • Collaborators revised (13)
    • Eligibility criteria expanded, about 3 words
  2. Notable Results first posted: Oct 24, 2017v7 Show 9 more changesShow less
    • Primary completion date: Oct 2013 to Oct 2024
    • Primary endpoints: 2 to 4
    • Enrollment target: 2776 to 2779
    • Study completion date: Jan 2015 to Jan 2025
    • Interventions: Boost Lifestyle (Behavioral), Group Lifestyle (Behavioral), Metformin (Drug) to DPPOS Boost Lifestyle (Behavioral), DPPOS Group Lifestyle (Behavioral), Intensive Lifestyle Group Session (Behavioral), Metformin (Drug)
    • Secondary endpoints revised (4)
    • Study description revised
    • Collaborators revised (13)
    • Publications: 46 to 47
  3. Notable Phase: Not specified to Phase 3v6 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 3250 to 2776
    • Primary completion date: Oct 2013
    • Study completion date: Jan 2015
    • Interventions: Boost Lifestyle (Behavioral), Group Lifestyle (Behavioral), Metformin (Drug)
    • Secondary endpoints: 2 to 4
    • Collaborators: 10 to 13
    • Publications: details revised at 1 of 46 entries
  4. Minor Collaborators: 9 to 10v5
  5. 2 versions Re-verified since Jan 21, 2010, no change to tracked fieldsv3-v4
  6. Notable Phase: Phase 3 to Not specifiedv2 Show 9 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: 3819 to 3250
    • Start date: Sep 2002
    • Interventions: lifestyle (Behavioral), metformin (Drug) to not stated
    • Study description expanded, about 21 words
    • Site details revised
    • Collaborators expanded, about 56 words
    • Study arms: 0 to 3
    • Study title expanded, about 2 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00038727
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA), National Institute on Minority Health and Health Disparities (NIMHD), National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), National Eye Institute (NEI), National Center for Research Resources (NCRR), Office of Research on Women's Health (ORWH), Centers for Disease Control and Prevention, American Diabetes Association, Indian Health Service (IHS), General Clinical Research Program, US Department of Veterans Affairs
Conditions
(from sponsor)
Diabetes Mellitus, Cancer, CVD
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2, Neoplasms, Obesity, Prediabetic State
Enrollment 2,779 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov