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Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00004992

Diabetes Prevention Program

A Phase 3 study testing Intensive lifestyle and Metformin in people with Diabetes Mellitus, Non-Insulin-Dependent and Glucose Intolerance, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United… Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
What is being tested?
Intensive lifestyle and Metformin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,234 participants
Where
1 siteUnited States
Study dates
Jul 1996to Apr 2001
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
  • BMI >= 24 kg/m2

Who cannot join

  • Underlying disease likely to limit life span and/or increase risk of interventions
  • Conditions or behaviors likely to effect conduct of the DPP
  • Diabetes or disordered glucose metabolism
  • Suboptimally treated Thyroid disease
  • Fasting triglyceride level < 600 mg/dl
  • Exclusions related to medications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd

    Rockville, Maryland, 20852

Other trials in United States

About this study

The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.

Being tested
Intensive lifestyle, Metformin, Placebo
Keywords
clinical trial, multi-center, NIDDM, NIDDK, Diabetes Prevention Program (DPP), diabetes risk factors, diabetes, glycemia, cardiovascular risk factors, quality of life, physical activity and nutrition, occurrence of adverse events, insulin secretion and sensitivity, prevention, abnormal glucose metabolism, lifestyle intervention, drug intervention
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance, Diabetes Mellitus, Motor Activity, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive lifestyleBehavioural

  • MetforminDrug

  • PlaceboDrug

Study groups in NCT00004992
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
MetforminActive comparatorNot described
Receives: Drug: Metformin
Intensive LifestyleActive comparatorNot described
Receives: Behavioral: Intensive lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of diabetes

    Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2000 (estimated)
  2. Study startJul 1996
  3. Primary completionApr 2001
  4. Study completionApr 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004992
Sponsor's protocol ID
(IND) - DPP (completed)
Other IDs
U01DK048489
Status last verified
Feb 2018
First submitted
17 Mar 2000
Last updated
2 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Florez JC, Jablonski KA, Bayley N, Pollin TI, de Bakker PI, Shuldiner AR, Knowler WC, Nathan DM, Altshuler D; Diabetes Prevention Program Research Group. TCF7L2 polymorphisms and progression to diabetes in the Diabetes Prevention Program. N Engl J Med. 2006 Jul 20;355(3):241-50. doi: 10.1056/NEJMoa062418.

    PubMed 16855264

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • Salive ME, Tjaden AH, Ames JR, Crandall JP, Dabelea D, Hazuda HP, Heckman-Stoddard BM, Huckfeldt PJ, Kuo S, Strotmeyer ES, Temprosa M, Venditti EM; DPP Research Group. Lifestyle and Metformin Interventions and Risk of Multimorbidity in Adults With Prediabetes. JAMA. 2026 Jun 15:e268492. doi: 10.1001/jama.2026.8492. Online ahead of print.

    PubMed 42295772

  • Lin PD, Cardenas A, Temprosa M, Botelho JC, Calafat AM, Gold DR, Oken E, Fleisch AF. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Cardiovascular Disease Incidence in Adults With Prediabetes: Findings From the Diabetes Prevention Program. J Am Heart Assoc. 2026 Jan 6;15(1):e046298. doi: 10.1161/JAHA.125.046298. Epub 2025 Dec 18.

    PubMed 41413398

  • Tjaden AH, Goldbaum AA, Edelstein SL, Heckman-Stoddard BM, Reedy J, Herman WH, Hoskin M, Knowler WC, Schlogl M, Temple KA, Venditti EM, Watson K, Temprosa M, Shams-White MM; DPP Research Group. The 2018 World Cancer Research Fund/American Institute for Cancer Research Score and Cancer Risk: results from the diabetes prevention program outcomes study. Am J Clin Nutr. 2025 Sep;122(3):715-723. doi: 10.1016/j.ajcnut.2025.07.011. Epub 2025 Jul 15.

    PubMed 40675492

  • Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.

    PubMed 40311647

  • Munshi MN, Venditti EM, Tjaden AH, Knowler WC, Boyko EJ, Middelbeek RJW, Luchsinger JA, Lee CG, Hazuda HP, Salive ME, Edelstein SL, Storer TW. Long-term impact of Diabetes Prevention Program interventions on walking endurance. Front Public Health. 2024 Dec 18;12:1470035. doi: 10.3389/fpubh.2024.1470035. eCollection 2024.

    PubMed 39744353

  • Molitch ME, Tripputi M, Levey AS, Crandall JP, Dabelea D, Herman WH, Knowler WC, Orchard TJ, Schroeder EB, Srikanthan P, Temprosa M, White NH, Nathan DM; Diabetes Prevention Program Research Group. Electronic address: dppmail@bsc.gwu.edu. Effects of metformin and intensive lifestyle interventions on the incidence of kidney disease in adults in the DPP/DPPOS. J Diabetes Complications. 2023 Sep;37(9):108556. doi: 10.1016/j.jdiacomp.2023.108556. Epub 2023 Jul 25.

    PubMed 37607422

  • Shams-White MM, Tjaden AH, Edelstein SL, Bassiouni S, Kahle LL, Kim C, Pi-Sunyer X, Temple KA, Venditti EM, Reedy J, Heckman-Stoddard BM; DPP Research Group. The 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score and diabetes risk in the Diabetes Prevention Program Outcomes Study (DPPOS). BMC Nutr. 2022 Sep 21;8(1):105. doi: 10.1186/s40795-022-00596-7.

    PubMed 36131333

  • Vazquez Arreola E, Knowler WC, Hanson RL. Weight Loss, Lifestyle Intervention, and Metformin Affect Longitudinal Relationship of Insulin Secretion and Sensitivity. J Clin Endocrinol Metab. 2022 Nov 23;107(11):3086-3099. doi: 10.1210/clinem/dgac509.

    PubMed 36062951

  • Goldberg RB, Orchard TJ, Crandall JP, Boyko EJ, Budoff M, Dabelea D, Gadde KM, Knowler WC, Lee CG, Nathan DM, Watson K, Temprosa M; Diabetes Prevention Program Research Group*. Effects of Long-term Metformin and Lifestyle Interventions on Cardiovascular Events in the Diabetes Prevention Program and Its Outcome Study. Circulation. 2022 May 31;145(22):1632-1641. doi: 10.1161/CIRCULATIONAHA.121.056756. Epub 2022 May 23.

    PubMed 35603600

  • Wander PL, Christophi CA, Araneta MRG, Boyko EJ, Enquobahrie DA, Dabelea D, Goldberg RB, Kahn SE, Kim C, Pi-Sunyer X, Knowler WC. Adiposity, related biomarkers, and type 2 diabetes after gestational diabetes: The Diabetes Prevention Program. Obesity (Silver Spring). 2022 Jan;30(1):221-228. doi: 10.1002/oby.23291. Epub 2021 Nov 18.

    PubMed 34796678

  • Lee CG, Heckman-Stoddard B, Dabelea D, Gadde KM, Ehrmann D, Ford L, Prorok P, Boyko EJ, Pi-Sunyer X, Wallia A, Knowler WC, Crandall JP, Temprosa M; Diabetes Prevention Program Research Group; Diabetes Prevention Program Research Group:. Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021 Dec;44(12):2775-2782. doi: 10.2337/dc21-1046. Epub 2021 Oct 25.

    PubMed 34697033

  • Varga TV, Liu J, Goldberg RB, Chen G, Dagogo-Jack S, Lorenzo C, Mather KJ, Pi-Sunyer X, Brunak S, Temprosa M; Diabetes Prevention Program Research Group. Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001953. doi: 10.1136/bmjdrc-2020-001953.

    PubMed 33789908

  • Goldberg RB, Tripputi MT, Boyko EJ, Budoff M, Chen ZZ, Clark JM, Dabelea DM, Edelstein SL, Gerszten RE, Horton E, Mather KJ, Perreault L, Temprosa M, Wallia A, Watson K, Irfan Z. Hepatic Fat in Participants With and Without Incident Diabetes in the Diabetes Prevention Program Outcome Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4746-e4765. doi: 10.1210/clinem/dgab160.

    PubMed 33705543

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensive lifestyle and Metformin in people with Diabetes Mellitus, Non-Insulin-Dependent and Glucose Intolerance, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of diabetes (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004992, which also lists 64 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.

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