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 A/S
ClinicalTrials.gov Identifier:
NCT00523042
First received: August 29, 2007
Last updated: March 26, 2014
Last verified: March 2014

August 29, 2007
March 26, 2014
August 2007
February 2008   (final data collection date for primary outcome measure)
Changes in lung function, chest X-rays, or asthma exacerbation frequency [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Changes in lung function, chest X-rays, or asthma exacerbation frequency [ Time Frame: after 52 weeks of treatment ]
Complete list of historical versions of study NCT00523042 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Diabetes control measured by change in HbA1c from baseline
  • Laboratory assessments (biochemistry, insulin antibodies, blood count)
  • Preprandial insulin doses
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Asthma
  • 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.
  • Experimental: A
    Intervention: Drug: inhaled human insulin
  • Active Comparator: B
    Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   India,   Malaysia,   United States
 
NCT00523042
NN1998-1616
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Conny N. Korsholm Novo Nordisk A/S
Novo Nordisk A/S
March 2014

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