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Diabetes Prevention Program Outcomes Study (DPPOS)

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ClinicalTrials.gov Identifier: NCT00038727
Recruitment Status : Active, not recruiting
First Posted : June 5, 2002
Results First Posted : October 24, 2017
Last Update Posted : April 23, 2019
Sponsor:
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
General Clinical Research Program
US Department of Veterans Affairs
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diabetes Mellitus
Cancer
CVD
Interventions Behavioral: DPPOS Group Lifestyle
Drug: Metformin
Behavioral: DPPOS Boost Lifestyle
Behavioral: Intensive Lifestyle Group Session
Enrollment 2779
Recruitment Details All surviving Diabetes Prevention Program (DPP) participants with consent were invited to enroll into DPPOS throughout the follow-up period. The majority of DPPOS participants were enrolled in 2002-2003.
Pre-assignment Details DPPOS covers 3 funding phases for the 3 study phases: DPPOS-1 (2002-2008), DPPOS-2 (2009-2014), DPPOS-3 (2015-2021). The groups are defined using the original randomized groups from DPP with recruitment period of 1996-1998.
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Hide Arm/Group Description

Boost / Lifestyle, previously Intensive Lifestyle during the DPP

Group Lifestyle: Quarterly group lifestyle sessions

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

Metformin / Lifestyle, previously the metformin treatment group during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day

Group Lifestyle, previously placebo treated participants during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Period Title: Overall Study
Started 916 [1] 927 [1] 936 [1]
DPPOS Phase 1 Primary 910 [2] 924 [2] 932 [2]
DPPOS Phase 2 Enrolled 915 [3] 926 [3] 935 [3]
DPPOS Phase 2 Primary 751 [3] 772 [3] 780 [3]
DPPOS Phase 3 Enrolled [4] 916 927 936
Completed 916 927 936
Not Completed 0 0 0
[1]
Includes all enrollees from DPPOS 1-3
[2]
As reported in the Lancet 2009
[3]
As reported in Lancet Diabetes and Endocrinology 2015
[4]
As of February 2016
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo Total
Hide Arm/Group Description

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

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

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

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

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.

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

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

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

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

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

Total of all reporting groups
Overall Number of Baseline Participants 916 927 936 2779
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 915 participants 927 participants 936 participants 2778 participants
54  (11) 54  (10) 54  (10) 54  (10)
[1]
Measure Analysis Population Description: An additional 3 participants were enrolled after publication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 916 participants 927 participants 936 participants 2779 participants
51.2  (11.1) 51.3  (10.1) 50.7  (10.0) 51.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 916 participants 927 participants 936 participants 2779 participants
Female
624
  68.1%
620
  66.9%
645
  68.9%
1889
  68.0%
Male
292
  31.9%
307
  33.1%
291
  31.1%
890
  32.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 916 participants 927 participants 936 participants 2779 participants
American Indian or Alaska Native
54
   5.9%
46
   5.0%
55
   5.9%
155
   5.6%
Asian
44
   4.8%
28
   3.0%
40
   4.3%
112
   4.0%
Native Hawaiian or Other Pacific Islander
8
   0.9%
1
   0.1%
1
   0.1%
10
   0.4%
Black or African American
173
  18.9%
182
  19.6%
189
  20.2%
544
  19.6%
White
596
  65.1%
628
  67.7%
612
  65.4%
1836
  66.1%
More than one race
19
   2.1%
21
   2.3%
19
   2.0%
59
   2.1%
Unknown or Not Reported
22
   2.4%
21
   2.3%
20
   2.1%
63
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 916 participants 927 participants 936 participants 2779 participants
916 927 936 2779
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 916 participants 927 participants 936 participants 2779 participants
33.7  (6.5) 33.8  (6.5) 34.0  (6.5) 33.8  (6.5)
1.Primary Outcome
Title Development of Diabetes.
Hide Description Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Time Frame Data from 2008 provides an average of 10 years of follow-up after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Hide Arm/Group Description:

Boost / Lifestyle, previously Intensive Lifestyle during the DPP

Group Lifestyle: Quarterly group lifestyle sessions

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

Metformin / Lifestyle, previously the metformin treatment group during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day

Group Lifestyle, previously placebo treated participants during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Overall Number of Participants Analyzed 916 927 936
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: diabetes incidence (cases per 100 person
5.3
(4.8 to 5.8)
6.4
(5.9 to 7.1)
7.8
(7.2 to 8.6)
2.Primary Outcome
Title Prevalence of Aggregate Microvascular Complication
Hide Description Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
Time Frame The years 2012-2013 reflect an average of 15 years of follow-up post randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Number with microvascular outcome data and included in the primary outcome analysis
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Hide Arm/Group Description:

Boost / Lifestyle, previously Intensive Lifestyle during the DPP

Group Lifestyle: Quarterly group lifestyle sessions

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

Metformin / Lifestyle, previously the metformin treatment group during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day

Group Lifestyle, previously placebo treated participants during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Overall Number of Participants Analyzed 751 772 780
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: average percentage of participants
11.3
(10.1 to 12.7)
13
(11.7 to 14.5)
12.4
(11.1 to 13.8)
3.Primary Outcome
Title Total Cancer Except Non-melanoma Skin Cancer
Hide Description All primary incident cancers except non-melanoma skin cancer
Time Frame The year 2021 will provide an average follow-up of 23 years since randomization.
Outcome Measure Data Not Reported
4.Primary Outcome
Title Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Hide Description Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Time Frame Year 2025 data reflects an average of 27 years of average follow-up.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Subclinical Atherosclerosis
Hide Description Measured using coronary artery calcification (CAC).
Time Frame The year 2012 provides an average of 14 years of average follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
DPPOS Participants who met eligibility criteria and consented to have CAC measurements - by sex
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Hide Arm/Group Description:

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

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

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

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

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.

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

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

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

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

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

Overall Number of Participants Analyzed 701 679 681
Geometric Mean (95% Confidence Interval)
Unit of Measure: CAC geometric mean in AU
Men Number Analyzed 468 participants 464 participants 486 participants
70.1
(45.4 to 108.2)
40.2
(26.1 to 61.9)
63.7
(41.3 to 98.3)
Women Number Analyzed 213 participants 215 participants 215 participants
6.0
(4.1 to 8.8)
6.1
(4.2 to 9.0)
5.3
(3.6 to 7.8)
6.Secondary Outcome
Title Cognitive Function
Hide Description Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ).
Time Frame The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020.
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Short Physical Performance Battery
Hide Description Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands.
Time Frame The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Frailty
Hide Description Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
Time Frame The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020.
Outcome Measure Data Not Reported
Time Frame Until data lock of Jan 2014, average of 15 years of follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Hide Arm/Group Description

Boost / Lifestyle, previously Intensive Lifestyle during the DPP

Group Lifestyle: Quarterly group lifestyle sessions

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

Metformin / Lifestyle, previously the metformin treatment group during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day

Group Lifestyle, previously placebo treated participants during DPP

Group Lifestyle: Quarterly group lifestyle sessions

All-Cause Mortality
1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   88/916 (9.61%)      85/927 (9.17%)      83/936 (8.87%)    
Show Serious Adverse Events Hide Serious Adverse Events
1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   472/916 (51.53%)      482/927 (52.00%)      492/936 (52.56%)    
General disorders       
Any SAE Report  1  472/916 (51.53%)  1099 482/927 (52.00%)  1122 492/936 (52.56%)  1103
1
Term from vocabulary, Costart dictionary
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Original Lifestyle 2 Original Metformin 3 Original Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   234/916 (25.55%)      274/927 (29.56%)      257/936 (27.46%)    
Musculoskeletal and connective tissue disorders       
Sprains and fractures requiring medical attention  1  234/916 (25.55%)  274/927 (29.56%)  257/936 (27.46%) 
1
Term from vocabulary, Costart dictionary
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marinella Temprosa, PI of Coordinating Center
Organization: George Washington University
Phone: 3018819260
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00038727     History of Changes
Obsolete Identifiers: NCT00353314
Other Study ID Numbers: IND - DK048489
U01DK048489 ( U.S. NIH Grant/Contract )
First Submitted: June 4, 2002
First Posted: June 5, 2002
Results First Submitted: February 21, 2017
Results First Posted: October 24, 2017
Last Update Posted: April 23, 2019