Primary Intervention With Mucosal Insulin (Pre-POINT)

April 19, 2017 updated by: University of Colorado, Denver

Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT )

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center for Childhood Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children aged 2 years to 7 years who:

    • Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);
    • Type 1 diabetes susceptible HLA DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and

    None of the following HLA DR or DQB1 alleles:

    • DR 11
    • DR 12
    • DQB1*0602
    • DR7-DQB1*0303
    • DR14-DQB1*0503 or
    • Have a sibling with T1DM;
    • Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;
  2. Islet autoantibody negative at time of recruitment.

Exclusion Criteria:

  1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
  2. Prior or current participation in another intervention trial.
  3. Chronic oral steroid use and/or other chronic oral immunosuppressant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral Placebo
Other: Oral Placebo
Oral Placebo is given orally daily
Experimental: Human Insulin
Oral Insulin at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg per day
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 Names:
  • Oral Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Glucose Levels
Time Frame: Day 1
Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin.
Day 1
Daily Evaluation of Blood Glucose Levels
Time Frame: Days 2 through 7
Blood glucose will be measured 60 minutes after the administration of the Insulin.
Days 2 through 7
Evaluation of Blood Glucose Levels
Time Frame: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.
After treatment day 7, Insulin will be administered and measured on a monthly basis.
Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total IgE and IgE.
Time Frame: 2 weeks, 3 months, 6 months
Allergy/intolerance to the study drug evaluated with total IgE and IgE antibodies to insulin at 2 weeks, 3 months, 6 months, then every 6 months thereafter, as well as monitored through self-reporting by families. Parents/guardians will be educated on and instructed to look out for possible allergic reactions to insulin.
2 weeks, 3 months, 6 months
T-cell responses related to potential immune response to Insulin
Time Frame: Day 1, 15 days, 3 and 6 months.
T-cell responses e.g. antibody and cell mediated immune results will be evaluated the day of administration then at 15 days, 3 and 6 months, and every 6 months of treatment, and will be reported directly to the Data Coordinating Center.
Day 1, 15 days, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Juvenile Diabetes Research Foundation
German Federal Ministry of Education and Research
University of Bristol
University Hospital Dresden
Diabetes Research Institute, Munich, Germany.

Investigators

  • Principal Investigator: Ezio Bonifacio, PhD, Medical Faculty Carl Gustav Carus, Dresden University of Technology
  • Principal Investigator: Georgeanna J Klingensmith, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-1043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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