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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00523042
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : August 30, 2007
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma Drug: insulin aspart Drug: inhaled human insulin Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 30, 2007
Actual Primary Completion Date : February 28, 2008
Actual Study Completion Date : February 28, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Active Comparator: B Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Other Names:
  • NovoRapid®
  • NovoLog®

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

Secondary Outcome Measures :
  1. Diabetes control measured by change in HbA1c [ Time Frame: from baseline to end of treatment ]
  2. Laboratory assessments (biochemistry, insulin antibodies, blood count) [ Time Frame: from baseline to end of treatment ]
  3. Preprandial insulin doses [ Time Frame: for the duration of the trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00523042

  Show 32 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00523042     History of Changes
Other Study ID Numbers: NN1998-1616
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Autoimmune Diseases
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs