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Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD) (iINHALE 8)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00472953
First received: May 11, 2007
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Chronic Obstructive Pulmonary Disease
 Drug: inhaled human insulin
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections [ Time Frame: After one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Reported Outcomes [ Time Frame: After one year ] [ Designated as safety issue: No ]
  • Diabetes control measured by change in HbA1c from baseline [ Time Frame: After one year ] [ Designated as safety issue: No ]
  • Preprandial Insulin Doses [ Time Frame: After one year ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Active Comparator: B Drug: insulin aspart
Treat-to-target dose titration scheme, pre-prandial, injection s.c.

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

Inclusion Criteria:

  • Chronic Obstructive Pulmonary Disease
  • Type 1 or type 2 diabetes
  • HbA1c lower or equal to 11.0 %
  • Body Mass Index (BMI) lower or equal to 40.0 kg/m2

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Current smoking or smoking within the last 6 months
  • Other pulmonary disease including asthma
  • Proliferative retinopathy or maculopathy requiring acute treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472953

Locations
Argentina
Buenos Aires, Argentina
India
Chandigarh, Punjab, India, 160012
Romania
Bucharest, Romania
Slovakia
Lubochna, Slovakia
Taiwan
Taipei, Taiwan
Thailand
Bangkok, Thailand
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Else Munksgaard Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00472953     History of Changes
Other Study ID Numbers: NN1998-1617, 2006-004731-29
Study First Received: May 11, 2007
Last Updated: May 22, 2012
Health Authority: Taiwan: Department of Health
Slovakia: State Institute for Drug Control
Turkey: Ministry of Health Drug and Pharmaceutical Department
Romania: National Medicines Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Thailand: Ministry of Public Health
India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013