Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

It had two arms (groups): TI Inhalation Powder (original protocol) (experimental) and TI Inhalation Powder and Humalog (Amendment 1) (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Clinical diagnoses of type 1 or type 2 diabetes mellitus. Body mass index (BMI) of \< or = 40 kg/m2. Non-smokers (never smoked or former smokers \[= 6 months since cessation\]) and a urine cotinine level \< or = 100 ng/dL. For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks; unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy); exposure to any investigational product(s) in the past 12 weeks.

How the Study Was Run

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

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.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-09 with completion listed for 2011-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects) (time frame: 0 to 240 minutes). Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects) (time frame: 0 to 240 minutes). Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) (time frame: 0 to 240 minutes).

It also tracked 4 secondary outcomes, for example Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects), Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects), Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) and Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 18 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 Lispro compound page, all human trials.