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 A/S
ClinicalTrials.gov Identifier:
NCT00472953
First received: May 11, 2007
Last updated: May 22, 2012
Last verified: May 2012
  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:


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

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
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: 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 A/S
Investigators
Study Director: Else Munksgaard Novo Nordisk A/S
  More Information

Additional Information:
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Respiratory Tract Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014