Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

What Was Tested

The trial (phase 1, phase 2) is built around Insulin Lispro.

It had five arms (groups): Inhaled insulin (LOM) (experimental), Inhaled insulin (MOM1) (experimental), Inhaled insulin (MOM2) (experimental), Inhaled insulin (HOM) (experimental) and subcutaneous insulin lispro (LIS) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The inhaler was configured to generate insulin aerosol particles sized 3.5-4.0 μm (low output mesh; LOM), 4.3-4.8 μm (medium output mesh; MOM) or 5.0-5.5 μm (high output mesh; HOM) during low inspiratory flow.

To assess within subject variability, MOM was used twice.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Body mass index 18.0 - 28.0 kg/m2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: active or chronic pulmonary disease; decompensated heart failure at any time or angina pectoris within the last 12 months or acute myocardial infarction at any time; proliferative retinopathy or severe neuropathy.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2013-05 with completion listed for 2013-07.

What Was Measured

The main thing measured (primary outcome): Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h) (time frame: 0 to 8 hours). Bioavailability (time frame: 0 to 8 hours).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Lispro in 12 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 Lispro compound page, all human trials.