Diabetes Prevention Program

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Glucose Intolerance
• Interventions: Drug: Placebo; Behavioral: Intensive lifestyle; Drug: Metformin

• Registration Number: NCT00004992
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-07
• Study First Submitted: 2000-03-17
• Study First Submitted QC: 2000-03-17
• Study First Posted: 2000-03-20
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Intensive Lifestyle	Intensive lifestyle	-
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Development of diabetes	Up to 5 years	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

Trial Locations

Locations (1)

George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd; 🇺🇸 Rockville, Maryland, United States