Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Plain-language guide to NCT00331604: phase 3 randomized trial of Insulin (regular human) and Insulin Aspart, 618 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00331604
Phase: phase 3
Status: terminated early
Start: 2006-08-31
Completion (planned or actual): 2008-05-05
Participants: 618 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 2
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human) and Insulin Aspart.

This trial is conducted in Asia, Europe and South America.

It had three arms (groups): A (experimental), B (active comparator) and C (active comparator).

The registry classes the interventions as drug.

More on the Plan

The decision to discontinue the development of AERx® is not due to any safety concerns.

Who Took Part

The registry lists 618 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Type 2 diabetes. Currently treated with insulin. Body mass index of (BMI) less than or equal to 40.0 kg/m2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: current smoking or smoking within the last 6 months; cardiac problems; uncontrolled hypertension.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

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

It started in 2006-08-31 with completion listed for 2008-05-05.

It ran at 73 sites in Germany (17), United Kingdom (12), Italy (11), Spain (9), France (8) and Brazil (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Treatment difference in HbA1c (time frame: After 52 weeks).

It also tracked 5 secondary outcomes, for example Adverse events, Blood glucose, Body weight, Lung function and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 618 people.

With 618 participants it is a large trial for this field.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Insulin Detemir: A long-acting basal insulin analog sold as Levemir.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.