Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00523042

Acronym

iINHALE 9

Enrollment

Registered

2007-08-30

Start date

2007-08-30

Completion date

2008-02-28

Last updated

2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma

Brief summary

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Detailed description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Interventions

DRUGinsulin aspart

Treat-to-target dose titration scheme, injection s.c.

DRUGinhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 1 or type 2 diabetes * Treatment with insulin and/or oral anti-diabetic drugs * Asthma for at least 6 months * Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years * HbA1C less than or equal to 11.0 % * Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

* Current smoking or smoking within the last 6 months * Other current acute or chronic pulmonary disease excluding asthma * Recurrent severe hypoglycaemia * Proliferative retinopathy or maculopathy

Design outcomes

Primary

Measure	Time frame
Changes in lung function, chest X-rays, or asthma exacerbation frequency	after 52 weeks of treatment

Secondary

Measure	Time frame
Diabetes control measured by change in HbA1c	from baseline to end of treatment
Laboratory assessments (biochemistry, insulin antibodies, blood count)	from baseline to end of treatment
Preprandial insulin doses	for the duration of the trial

Countries

Australia, India, Malaysia, Serbia and Montenegro, Slovakia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026