Trial Outcomes & Findings for Diabetes Prevention Program Outcomes Study (NCT NCT00038727)
NCT ID: NCT00038727
Last Updated: 2021-12-28
Results Overview
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).
UNKNOWN
PHASE3
2779 participants
Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
2021-12-28
Participant Flow
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.
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.
Participant milestones
| Measure |
1 Original Lifestyle
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.
|
2 Original Metformin
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Overall Study
STARTED
|
916
|
927
|
936
|
|
Overall Study
DPPOS Phase 1 Primary
|
910
|
924
|
932
|
|
Overall Study
DPPOS Phase 2 Enrolled
|
915
|
926
|
935
|
|
Overall Study
DPPOS Phase 2 Primary
|
751
|
772
|
780
|
|
Overall Study
DPPOS Phase 3 Enrolled
|
916
|
927
|
936
|
|
Overall Study
COMPLETED
|
916
|
927
|
936
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An additional 3 participants were enrolled after publication
Baseline characteristics by cohort
| Measure |
1 Original Lifestyle
n=916 Participants
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
|
2 Original Metformin
n=927 Participants
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
|
3 Original Placebo
n=936 Participants
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
n=2779 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 11.1 • n=916 Participants
|
51.3 years
STANDARD_DEVIATION 10.1 • n=927 Participants
|
50.7 years
STANDARD_DEVIATION 10.0 • n=936 Participants
|
51.1 years
STANDARD_DEVIATION 10.4 • n=2779 Participants
|
|
Sex: Female, Male
Female
|
624 Participants
n=916 Participants
|
620 Participants
n=927 Participants
|
645 Participants
n=936 Participants
|
1889 Participants
n=2779 Participants
|
|
Sex: Female, Male
Male
|
292 Participants
n=916 Participants
|
307 Participants
n=927 Participants
|
291 Participants
n=936 Participants
|
890 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
54 Participants
n=916 Participants
|
46 Participants
n=927 Participants
|
55 Participants
n=936 Participants
|
155 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=916 Participants
|
28 Participants
n=927 Participants
|
40 Participants
n=936 Participants
|
112 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=916 Participants
|
1 Participants
n=927 Participants
|
1 Participants
n=936 Participants
|
10 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
Black or African American
|
173 Participants
n=916 Participants
|
182 Participants
n=927 Participants
|
189 Participants
n=936 Participants
|
544 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
White
|
596 Participants
n=916 Participants
|
628 Participants
n=927 Participants
|
612 Participants
n=936 Participants
|
1836 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=916 Participants
|
21 Participants
n=927 Participants
|
19 Participants
n=936 Participants
|
59 Participants
n=2779 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=916 Participants
|
21 Participants
n=927 Participants
|
20 Participants
n=936 Participants
|
63 Participants
n=2779 Participants
|
|
Region of Enrollment
United States
|
916 participants
n=916 Participants
|
927 participants
n=927 Participants
|
936 participants
n=936 Participants
|
2779 participants
n=2779 Participants
|
|
BMI
|
33.7 kg/m2
STANDARD_DEVIATION 6.5 • n=916 Participants
|
33.8 kg/m2
STANDARD_DEVIATION 6.5 • n=927 Participants
|
34.0 kg/m2
STANDARD_DEVIATION 6.5 • n=936 Participants
|
33.8 kg/m2
STANDARD_DEVIATION 6.5 • n=2779 Participants
|
PRIMARY outcome
Timeframe: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).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).
Outcome measures
| Measure |
1 Original Lifestyle
n=916 Participants
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.
|
2 Original Metformin
n=927 Participants
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=936 Participants
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Development of Diabetes.
|
5.3 diabetes incidence (cases per 100 person
Interval 4.8 to 5.8
|
6.4 diabetes incidence (cases per 100 person
Interval 5.9 to 7.1
|
7.8 diabetes incidence (cases per 100 person
Interval 7.2 to 8.6
|
PRIMARY outcome
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).Population: Number with microvascular outcome data and included in the primary outcome analysis
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).
Outcome measures
| Measure |
1 Original Lifestyle
n=751 Participants
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.
|
2 Original Metformin
n=772 Participants
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=780 Participants
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Prevalence of Aggregate Microvascular Complication
|
11.3 average percentage of participants
Interval 10.1 to 12.7
|
13 average percentage of participants
Interval 11.7 to 14.5
|
12.4 average percentage of participants
Interval 11.1 to 13.8
|
PRIMARY outcome
Timeframe: Outcomes were assessed from 1996-2020 (approximately 24 years).All primary incident cancers except non-melanoma skin cancer
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Outcomes were assessed from 1996-2025 (approximately 29 years).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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).Population: DPPOS Participants who met eligibility criteria and consented to have CAC measurements - by sex
Measured using coronary artery calcification (CAC).
Outcome measures
| Measure |
1 Original Lifestyle
n=701 Participants
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.
|
2 Original Metformin
n=679 Participants
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=681 Participants
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Subclinical Atherosclerosis
Men
|
70.1 CAC geometric mean in AU
Interval 45.4 to 108.2
|
40.2 CAC geometric mean in AU
Interval 26.1 to 61.9
|
63.7 CAC geometric mean in AU
Interval 41.3 to 98.3
|
|
Subclinical Atherosclerosis
Women
|
6.0 CAC geometric mean in AU
Interval 4.1 to 8.8
|
6.1 CAC geometric mean in AU
Interval 4.2 to 9.0
|
5.3 CAC geometric mean in AU
Interval 3.6 to 7.8
|
SECONDARY outcome
Timeframe: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.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 ).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.Population: All randomized to DPP were included
All cause-mortality through clinic reports and National Death Index search
Outcome measures
| Measure |
1 Original Lifestyle
n=1079 Participants
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.
|
2 Original Metformin
n=1073 Participants
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=1082 Participants
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Mortality
|
158 Participants
|
152 Participants
|
143 Participants
|
Adverse Events
1 Original Lifestyle
2 Original Metformin
3 Original Placebo
Serious adverse events
| Measure |
1 Original Lifestyle
n=916 participants at risk
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.
|
2 Original Metformin
n=927 participants at risk
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=936 participants at risk
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
General disorders
Any SAE Report
|
51.5%
472/916 • Number of events 1099 • Until data lock of Jan 2014, average of 15 years of follow-up
|
52.0%
482/927 • Number of events 1122 • Until data lock of Jan 2014, average of 15 years of follow-up
|
52.6%
492/936 • Number of events 1103 • Until data lock of Jan 2014, average of 15 years of follow-up
|
Other adverse events
| Measure |
1 Original Lifestyle
n=916 participants at risk
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.
|
2 Original Metformin
n=927 participants at risk
Metformin / Lifestyle, previously the metformin treatment group during DPP
Group Lifestyle: Quarterly group lifestyle sessions
Metformin: Administered as 850mg twice per day
|
3 Original Placebo
n=936 participants at risk
Group Lifestyle, previously placebo treated participants during DPP
Group Lifestyle: Quarterly group lifestyle sessions
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Sprains and fractures requiring medical attention
|
25.5%
234/916 • Until data lock of Jan 2014, average of 15 years of follow-up
|
29.6%
274/927 • Until data lock of Jan 2014, average of 15 years of follow-up
|
27.5%
257/936 • Until data lock of Jan 2014, average of 15 years of follow-up
|
Additional Information
Marinella Temprosa, PI of Coordinating Center
George Washington University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place