Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Plain-language guide to NCT00322257: phase 3 randomized trial of Insulin (regular human) and Insulin Aspart, 596 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00322257
Phase: phase 3
Status: terminated early
Start: 2006-05-01
Completion (planned or actual): 2008-04-02
Participants: 596 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 1
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 the United States of America (USA) and Canada.

It had two arms (groups): A (experimental) and B (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

Enrollment: 596 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: Type 1 diabetes. Body mass index (BMI) less than or equal to 40.0 kg/m2.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: current smoking or smoking within the last 6 months; impaired hepatic or renal function; cardiac problems.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2006-05-01 with completion listed for 2008-04-02.

It ran at 96 sites in United States (86) and Canada (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: After 52 weeks).

It also tracked 6 secondary outcomes, for example Body weight, Antibodies, Hypoglycemia, Pulmonary Function and Fasting plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 596 people.

With 596 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.