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

Phase 3

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Asthma
• Interventions: Drug: insulin aspart; Drug: inhaled human insulin

• Registration Number: NCT00523042
• Lead Sponsor: Novo Nordisk A/S

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.

Study Timeline

• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-29
• Study Start: 2007-08-30
• Study First Posted: 2007-08-30
• Primary Completion: 2008-02-28
• Study Completion: 2008-02-28
• Status Verified: 2018-09
• Disposition First Submitted: 2018-09-03
• Disposition First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Disposition First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	insulin aspart	-
A	inhaled human insulin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Preprandial insulin doses	for the duration of the trial
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Zilina, Slovakia