The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)

Summary

The Diabetes Prevention Trial of Type 1 (DPT-1) was a multicenter randomized, controlled clinical trial designed to determine whether it is possible to delay or prevent the clinical onset of type 1 diabetes through daily doses of insulin in individuals determined to be at risk for the disease. Subjects were recruited from study clinics and through media campaigns.First-degree relatives, 3 to 45 years of age, and second-degree relatives, 3 to 20 years of age, of patients with diabetes were screened for islet-cell antibodies. Those individuals found to be at high risk of diabetes were randomized to receive either close observation or low-dose parenteral insulin. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients were followed for up to six years.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Parenteral Insulin

Subcutaneous injections of recombinant human ultralente insulin in the morning and in the evening; the initial dose for each injection was 0.125 U per kilogram of body weight.

OTHER

Close Observation

Study visits every 6 months including an oral glucose tolerance test

DRUG

Oral Insulin

Capsules oral insulin, 7.5 mg of recombinant human insulin crystals

DRUG

Placebo

Placebo for oral insulin

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Office of Research on Women's Health (ORWH)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Jay S. Skyler, MD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1994-02-28

Primary Completion

2003-06-30

Completion

2003-06-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations