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See termination reason in detailed description
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | Drug | Treat-to-target dose titration scheme, injection s.c. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lung function, chest X-rays, or asthma exacerbation frequency | after 52 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes control measured by change in HbA1c | from baseline to end of treatment | |
| Laboratory assessments (biochemistry, insulin antibodies, blood count) | from baseline to end of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Fresno | California | 93720 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| inhaled human insulin | Drug | Treat-to-target dose titration scheme, inhalation. |
|
| Preprandial insulin doses |
| for the duration of the trial |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64108 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43210 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Ogden | Utah | 84403 | United States |
| Novo Nordisk Investigational Site | Spokane | Washington | 99208 | United States |
| Novo Nordisk Investigational Site | Broadmeadow | New South Wales | 2292 | Australia |
| Novo Nordisk Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Novo Nordisk Investigational Site | Keswick | South Australia | 5035 | Australia |
| Novo Nordisk Investigational Site | Box Hill | Victoria | 3128 | Australia |
| Novo Nordisk Investigational Site | East Ringwood | Victoria | 3135 | Australia |
| Novo Nordisk Investigational Site | Parkville | Victoria | 3052 | Australia |
| Novo Nordisk Investigational Site | Auchenflower | 4066 | Australia |
| Novo Nordisk Investigational Site | Kippa-Ring | 4021 | Australia |
| Novo Nordisk Investigational Site | Chandigarh | Punjab | 160012 | India |
| Novo Nordisk Investigational Site | Vellore | Tamil Nadu | 632004 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700020 | India |
| Novo Nordisk Investigational Site | Hyderabad | 600034 | India |
| Novo Nordisk Investigational Site | Mumbai | 400 067 | India |
| Novo Nordisk Investigational Site | Pune | 411011 | India |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Pulau Pinang | 10990 | Malaysia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Košice | 04190 | Slovakia |
| Novo Nordisk Investigational Site | Ľubochňa | 03491 | Slovakia |
| Novo Nordisk Investigational Site | Moldava nad Bodvou | 045 01 | Slovakia |
| Novo Nordisk Investigational Site | Žilina | 01001 | Slovakia |
| Novo Nordisk Investigational Site | Žilina | 01207 | Slovakia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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