Primary Intervention With Mucosal Insulin

Phase 2CompletedNCT02620553

University of Colorado, Denver25 enrolled

Overview

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)

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Human InsulinDRUG

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)

Oral PlaceboOTHER

Oral Placebo is given orally daily

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in Blood Glucose Levels

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.

Time frame: Day 1

Daily Evaluation of Blood Glucose Levels

Blood glucose will be measured 60 minutes after the administration of the Insulin.

Time frame: Days 2 through 7

Evaluation of Blood Glucose Levels

After treatment day 7, Insulin will be administered and measured on a monthly basis.

Time frame: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.

Secondary Outcomes

Change in Total IgE and IgE.

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.

Time frame: 2 weeks, 3 months, 6 months

T-cell responses related to potential immune response to Insulin

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.

Time frame: Day 1, 15 days, 3 and 6 months.

Data from ClinicalTrials.gov

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