Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322257

Enrollment

596

Registered

2006-05-05

Start date

2006-05-01

Completion date

2008-04-02

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

Brief summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 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 No maximum

Healthy volunteers

Inclusion criteria

* Type 1 diabetes * HbA1c less than or equal to 11% * Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

* Total daily insulin dosage more than 100 IU or U/day. * Current smoking or smoking within the last 6 months * Impaired hepatic or renal function * Cardiac problems * Uncontrolled hypertension * Current proliferative retinopathy or maculopathy requiring acute treatment

Design outcomes

Primary

Measure	Time frame
HbA1c	After 52 weeks

Secondary

Measure	Time frame
Antibodies	after 52 weeks
Hypoglycemia	For the duration of the trial
Body weight	after 52 weeks
Pulmonary Function	For the duration of the trial
Fasting plasma glucose	after 52 weeks
Insulin doses	For the duration of the trial

Countries

Canada, United States

Outcome results

None listed

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