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Diabetes Prevention Program

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Non-Insulin-Dependent
Glucose Intolerance

Treatments

Behavioral: Intensive lifestyle
Drug: Placebo
Drug: Metformin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00004992
U01DK048489 (U.S. NIH Grant/Contract)
(IND) - DPP (completed)

Details and patient eligibility

About

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.

Enrollment

3,234 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

3,234 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Metformin
Active Comparator group
Treatment:
Drug: Metformin
Intensive Lifestyle
Active Comparator group
Treatment:
Behavioral: Intensive lifestyle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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