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Completed

NCT Number: NCT02620553

Primary Intervention With Mucosal Insulin

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)

Completed

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Islet autoantibody negative at time of recruitment.

Exclusion criteria

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

Treatment and study plan

human insulin

Drug

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

Oral Placebo

Other

Oral Placebo is given orally daily

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

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 )

Acronym: Pre-POINT

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Dec 3, 2015
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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