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

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.
ClinicalTrials.gov Identifier: NCT00472953
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : May 14, 2007
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Chronic Obstructive Pulmonary Disease Drug: inhaled human insulin Drug: insulin aspart 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 : 38 participants
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
Actual Study Start Date : May 15, 2007
Primary Completion Date : March 5, 2008
Study Completion Date : March 5, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections [ Time Frame: After one year ]

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


Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

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