CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 2,779 enrolled
Drug / intervention
Metformin +3 moredrug
Likely dose
Metformin 850mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00038727
NCT00038727Phase 3Unknown

Diabetes Prevention Program Outcomes Study

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jun 5, 2002·Updated Dec 28, 2021

In Brief

A Phase 3 clinical trial evaluating DPPOS Group Lifestyle, Metformin, and 2 other interventions for Diabetes Mellitus and 2 related conditions. Targeting 2,779 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

Phase 3UnknownOverdue
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2002
Enrollment StartSep 1, 2002
Primary CompletionOct 1, 2024
Study CompletionJan 1, 2025
TodayJul 2, 2026
Enrollment to primary: 22.1 yearsPosted 24.1 years ago

Interventions

DPPOS Group Lifestylebehavioral

Quarterly group lifestyle sessions

Metformindrug

Administered as 850mg twice per day, masked in DPP and open label in DPPOS

DPPOS Boost Lifestylebehavioral

In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.

Intensive Lifestyle Group Sessionbehavioral

16 session curriculum in group format. In DPP delivered to ILS as individual sessions