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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00472953
First received: May 11, 2007
Last updated: February 28, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Patient Reported Outcomes [ Time Frame: After one year ]
  • Diabetes control measured by change in HbA1c from baseline [ Time Frame: After one year ]
  • Preprandial Insulin Doses [ Time Frame: After one year ]

Enrollment: 38
Actual Study Start Date: May 15, 2007
Study Completion Date: March 5, 2008
Primary Completion Date: March 5, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425AGC
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, Argentina, 1280
India
Novo Nordisk Investigational Site
Chandigarh, Punjab, India, 160012
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India, 632004
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700020
Novo Nordisk Investigational Site
Hyderabad, India, 600034
Novo Nordisk Investigational Site
Mumbai, India, 400 067
Novo Nordisk Investigational Site
Pune, India, 411011
Romania
Novo Nordisk Investigational Site
Bucharest, Romania, 020475
Novo Nordisk Investigational Site
Bucharest, Romania, 020992
Slovakia
Novo Nordisk Investigational Site
Kosice, Slovakia, 04190
Novo Nordisk Investigational Site
Lubochna, Slovakia, 03491
Novo Nordisk Investigational Site
Moldava nad Bodvou, Slovakia, 045 01
Novo Nordisk Investigational Site
Zilina, Slovakia, 01001
Novo Nordisk Investigational Site
Zilina, Slovakia, 01207
Taiwan
Novo Nordisk Investigational Site
Changhua, Taiwan, 500
Novo Nordisk Investigational Site
Chiayi City, Taiwan, 600
Novo Nordisk Investigational Site
Taipei, Taiwan, 231
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10700
Turkey
Novo Nordisk Investigational Site
Erzurum, Turkey, 25240
Novo Nordisk Investigational Site
Gaziantep, Turkey, 27070
Novo Nordisk Investigational Site
Istanbul, Turkey, 34400
Novo Nordisk Investigational Site
Istanbul, Turkey, 34722
Novo Nordisk Investigational Site
Istanbul, Turkey, 34890
Novo Nordisk Investigational Site
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00472953     History of Changes
Other Study ID Numbers: NN1998-1617
2006-004731-29 ( EudraCT Number )
Study First Received: May 11, 2007
Last Updated: February 28, 2017

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

ClinicalTrials.gov processed this record on August 23, 2017