Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

It had two arms (groups): Technosphere® Insulin Inhalation Powder (TI) (experimental) and Comparator (active comparator).

Insulin Glargine and Technosphere® Insulin Inhalation Powder.

Insulin Glargine and Insulin Aspart.

The registry classes the interventions as drug.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Men and women ≥ 18 and ≤ 80 years of age. Clinical diagnosis of type 2 diabetes mellitus for more than 12 months. Body mass index (BMI) ≤ 45 kg/m2. Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months. Office spirometry at the investigator site.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: current or prior treatment with prandial or premix (70/30) insulin; history of insulin pump use within 6 weeks of visit 1; treatment with glucagon-like peptide (glp-1) analog drugs within the preceding 12 weeks of visit 1.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-09 with completion listed for 2011-08.

It ran at 29 sites in United States (29).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (%) From Baseline to Week 16 (time frame: Baseline to Week 16).

It also tracked 25 secondary outcomes, for example To Evaluate the Effect of Each Treatment on HbA1c, Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study, Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study, Glycomark and Fructosamine Levels Measured Throughout the Study, Seven-point Glucose at Randomization and Throughout the Study and Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 39 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.