Primary Intervention With Mucosal Insulin

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human).

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

It had two arms (groups): Human Insulin (experimental) and Placebo (placebo comparator).

Oral Placebo.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 2 years up to 7 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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);. 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.

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2007-09 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change in Blood Glucose Levels (time frame: Day 1). Daily Evaluation of Blood Glucose Levels (time frame: Days 2 through 7). Evaluation of Blood Glucose Levels.

It also tracked 2 secondary outcomes, for example Change in Total IgE and IgE and T-cell responses related to potential immune response to Insulin.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.