Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

What Was Tested

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

It had three arms (groups): Technosphere® Insulin with MedTone C Inhaler (experimental), Aspart Group (active comparator) and Technosphere ® Insulin-Gen2 Group (experimental).

Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry.

Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry.

Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry.

The registry classes the interventions as drug.

More on the Plan

This trial will employ a variety of methods to intensively manage these subjects.

Who Took Part

Enrollment: 518 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Men and women = 18 years of age. Clinical diagnosis of type 1 diabetes mellitus for at least 12 months. Body mass index (BMI) = 38 kg/m2. Subject willingness to not use CGM during the entire course of the trial. Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months.

The full record lists 11 inclusion and 17 exclusion criteria; among the exclusions: history of inhaled insulin use in the previous 6 months; history of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect hba1c measurements; history of copd, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2011-09 with completion listed for 2013-05.

It ran at 90 sites in United States (58), Russia (21), Ukraine (9) and Brazil (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline to Week 24 in HbA1c (time frame: Baseline to Week 24).

It also tracked 6 secondary outcomes, for example FEV1 Change From Baseline to Week 24, FPG Change From Baseline to Week 24, Mean 7-point Glucose Baseline Values, Mean 7-point Glucose Week 24 Values and Change in Body Weight From Baseline to Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 518 people.

With 518 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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