Primary Intervention With Mucosal Insulin

Summary

A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.

Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.

Accrual Objective 25 (3:2 randomization to active and control arms)

Conditions

• Type 1 Diabetes

Interventions

DRUG

Human Insulin

There is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day)

OTHER

Oral Placebo

Oral Placebo is given orally daily

Sponsors & Collaborators

• University Hospital Dresden

  collaborator OTHER

• Diabetes Research Institute, Munich, Germany.

  collaborator UNKNOWN

• University of Bristol

  collaborator OTHER

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Ezio Bonifacio, PhD · Medical Faculty Carl Gustav Carus, Dresden University of Technology

• Georgeanna J Klingensmith, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2013-06-30

Completion

2014-01-31

Countries

• United States

Study Locations