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This trial is conducted in Oceania.
The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled human insulin | Drug | |||
| insulin aspart | Drug | |||
| insulin NPH | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Long term pulmonary safety profiles | during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic control as measured by HbA1c | ||
| Incidence of hypoglycaemic episodes | ||
| Long-term safety profiles (laboratory, ECG, insulin antibodies) |
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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 | Broadmeadow | New South Wales | 2292 | Australia | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Physical examination and body weight and vital signs |
| Adverse events |
| Treatment satisfaction |
| Camperdown |
| New South Wales |
| 2050 |
| Australia |
| Novo Nordisk Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Novo Nordisk Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| Novo Nordisk Investigational Site | Woolloongabba | Queensland | 4102 | Australia |
| Novo Nordisk Investigational Site | Keswick | South Australia | 5035 | Australia |
| Novo Nordisk Investigational Site | Fremantle | Western Australia | 6160 | Australia |
| Novo Nordisk Investigational Site | Ashford | 5035 | Australia |
| Novo Nordisk Investigational Site | Auckland | Australia |
| Novo Nordisk Investigational Site | Box Hill | 3128 | Australia |
| Novo Nordisk Investigational Site | Christchurch | Australia |
| Novo Nordisk Investigational Site | Clayton | 3168 | Australia |
| Novo Nordisk Investigational Site | Garran | 2605 | Australia |
| Novo Nordisk Investigational Site | Heidelberg | 3085 | Australia |
| Novo Nordisk Investigational Site | Parkville | 3050 | Australia |
| Novo Nordisk Investigational Site | Perth | 6000 | Australia |
| Novo Nordisk Investigational Site | Randwick | 2031 | Australia |
| Novo Nordisk Investigational Site | Stones Corner | 4120 | Australia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| 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 |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D007336 | Insulin, Isophane |
| 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 |
| D049528 | Insulin, Long-Acting |
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