Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)

This study has been terminated.

(See termination reason in detailed description)

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00523042

First received: August 29, 2007

Last updated: May 21, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2007

Last Updated Date

May 21, 2012

Start Date ^ICMJE

August 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in lung function, chest X-rays, or asthma exacerbation frequency [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Changes in lung function, chest X-rays, or asthma exacerbation frequency [ Time Frame: after 52 weeks of treatment ]

Change History

Complete list of historical versions of study NCT00523042 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Diabetes control measured by change in HbA1c [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
Laboratory assessments (biochemistry, insulin antibodies, blood count) [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
Preprandial insulin doses [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Diabetes control measured by change in HbA1c from baseline
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Preprandial insulin doses

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Other Names:
- NovoRapid®
- NovoLog®
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.

Study Arm (s)

Experimental: A
Intervention: Drug: inhaled human insulin
Active Comparator: B
Intervention: Drug: insulin aspart

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, India, Malaysia

Administrative Information

NCT Number ^ICMJE

NCT00523042

Other Study ID Numbers ^ICMJE

NN1998-1616, 2006-004622-81

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Conny N. Korsholm

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top