PK/PD Study of Intranasal Insulin in Type I Diabetes

What Was Tested

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive. Treated with multiple daily insulin injections ≥ 12 months or an insulin pump. BMI between 18-28 kg/m², inclusive. Signed, written IRB-approved informed consent.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: history of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization; known allergy to trial product or any other ingredient in the study drug; positive hiv 1 (human immunodeficiency virus) antibody test, hepatitis b (anti-hbsag) or hepatitis c (anti-hcv) antibody test.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Insulin tolerability, PK, and PD (time frame: 120 minutes).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Lispro in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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