Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler

What Was Tested

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

It had two arms (groups): Regular Human Insulin (active comparator) and TI and Regular Human Insulin (experimental).

Subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

35 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis. Good venous access for blood draws. No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (\< 100 ng/mL). Body mass index (BMI) \< 32 kg/m2. Written informed consent provided.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: history of coronary artery disease, peripheral vascular disease, or congestive heart failure; allergy to study drug, food, or other study material (eg, peanuts, soy products); history of asthma, copd, or any other clinically relevant chronic lung disease.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin (regular human) 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 (regular human) and the comparison at some point, usually with a gap in between.

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

It started in 2011-12 with completion listed for 2012-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 3 secondary outcomes, for example Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI and Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 35 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.