Diabetes Prevention Program

Glucose Intolerance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004992
• Other study ID #: (IND) - DPP (completed)
• Secondary ID: U01DK048489
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2000
• Last updated: February 28, 2018
• Start date: July 1996
• Est. completion date: April 2001

Study information

• Verified date: February 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3234
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)

• BMI >= 24 kg/m2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Glucose Intolerance

Intervention

Behavioral:
• Intensive lifestyle

Drug:
• Metformin

• Placebo

Locations

Country	Name	City	State
United States	George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd	Rockville	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 20 — View Citation

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):393-40 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 5 years