Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00331604

Enrollment

618

Registered

2006-05-31

Start date

2006-08-31

Completion date

2008-05-05

Last updated

2017-03-01

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

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

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

DRUGinhaled human insulin

Treat-to-target dose titration scheme, inhalation.

DRUGinsulin detemir

Injection s.c., 50% of daily dose.

DRUGinsulin aspart

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Currently treated with insulin * Body mass index of (BMI) less than or equal to 40.0 kg/m2 * HbA1c less than or equal to 11.0%

Exclusion criteria

* Total daily insulin dosage less than or equal to 100 IU or U/day * Current smoking or smoking within the last 6 months * Cardiac problems * Uncontrolled hypertension * Current proliferative retinopathy or maculopathy

Design outcomes

Primary

Measure	Time frame
Treatment difference in HbA1c	After 52 weeks

Secondary

Measure	Time frame
Adverse events	For the duration of the trial
Blood glucose	After 52, 104 and 116 weeks of treatment
Body weight	During treatment
Lung function	After 52, 104 and 116 weeks of treatment
Hypoglycaemia	From 12 weeks of treatment

Countries

Brazil, Denmark, France, Germany, Hong Kong, Israel, Italy, Singapore, Spain, Taiwan, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026