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
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Asthma
Drug: insulin aspart
Drug: inhaled human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: August 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523042

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
United States, Utah
Novo Nordisk Clinical Trial Call Center
Ogden, Utah, United States, 84403
Australia, South Australia
Keswick, South Australia, Australia, 5035
India
Hyderabad, India, 600034
Malaysia
Georgetown, Penang, Malaysia, 10450
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Conny N. Korsholm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00523042     History of Changes
Other Study ID Numbers: NN1998-1616
Study First Received: August 29, 2007
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration
Serbia: Medicines and Medical Devices Agency of Serbia
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Ministry of Health
Malaysia: Ministry of Health
Slovakia: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on October 16, 2014