Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

It had two arms (groups): TI + Insulin glargine (experimental) and BPR 70/30 (active comparator).

Technosphere® Insulin Inhalation Powder + insulin glargine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 677 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 or women ≥ 18 and ≤ 80 years old. Clinical diagnosis of type 2 diabetes mellitus. BMI ≤ 40 kg/m2. Negative smoking status and urine cotinine test. Written informed consent.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks; treatment with pramlintide acetate (symlin®), and/or any incretins (e.g., exenatide \[byetta®\]) within the preceding 8 weeks; exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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 2006-02 with completion listed for 2008-08.

It ran at 151 sites in United States (80), Russia (16), Brazil (12), Spain (9), Argentina (7) and Poland (7).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change From Baseline in HbA1c to Week 52 (time frame: Baseline to Week 52).

It also tracked 7 secondary outcomes, for example Change From Baseline in Weight to Week 52, Change From Baseline in Fasting Plasma Glucose to Week 52, Incidence of Total Hypoglycemia, Incidence of Severe Hypoglycemia, Total Hypoglycemia Event Rate and Severe Hypoglycemia Event Rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 677 people.

With 677 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.