Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Plain-language guide to NCT00348712: phase 3 randomized trial of Insulin (regular human), 301 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00348712
Phase: phase 3
Status: terminated early
Start: 2006-10-30
Completion (planned or actual): 2008-03-05
Participants: 301 (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

This registered phase 3 trial tested Insulin (regular human).

This trial is conducted in Europe.

It had two arms (groups): A (active comparator) 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

301 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 2 diabetes. Treated with OAD(s) for more than or equal to 2 months. Body mass index of (BMI) less than or equal to 40.0 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: recurrent major hypoglycaemia; current smoking or smoking within the last 6 months; impaired hepatic or renal function.

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 (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 2006-10-30 with completion listed for 2008-03-05.

It ran at 74 sites in Germany (19), United Kingdom (14), France (11), Spain (10), Netherlands (8) and Austria (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Treatment difference in HbA1c (time frame: After 26 weeks).

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 301 people.

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, all human trials.

Our Notes on the Compound

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 (regular human) in the library

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.