Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere Insulin with those of subcutaneous (SC) regular human insulin.

It had two arms (groups): Technosphere Insulin (experimental) and Actrapid (active comparator).

Technosphere Insulin Inhalation Powder.

Subcutaneous regular human insulin.

The registry classes the interventions as drug.

Who Took Part

13 actual participants took part.

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: Clinical Diagnosis of type 2 diabetes mellitus. 18 to 65 years old. Body Mass Index \<35kg/m2. Non-smoker for at least 2 years. Written informed consent.

The full record lists 10 inclusion and 20 exclusion criteria; among the exclusions: diabetes mellitus type 1; current treatment (within the last 30 days) with oral anti-diabetic agents; HIstory of hypersensitivity to the drug or to drugs with similar chemical structures.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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.

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2004-02 with completion listed for 2004-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin (time frame: crossover approx every 2 weeks for up to 10 weeks). Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min) (time frame: crossover approx every 2 weeks for up to 10 weeks).

It also tracked 2 secondary outcomes, for example Safety variables included adverse events, HbA1c, pulmonary function tests, and diabetes-specific signs (ie, hypoglycemia and hyperglycemia).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 13 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.