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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004623-12 | EudraCT Number |
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See termination reason in detailed description
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This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
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 | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled human insulin | Drug | Treat-to-target dose titration scheme, pre-prandial, inhalation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change from baseline | After 18 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | For the duration of the trial | |
| Body weight | after 18 weeks of treatment | |
| Lung function |
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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 | Buenos Aires | B1636DSU | Argentina | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| metformin | Drug | Tablets, 2000 mg/day. |
|
| glimepiride | Drug | Tablets, 4 mg/day. |
|
| inhaled human insulin | Drug | Treat-to-target dose titration scheme, post-prandial, inhalation. |
|
|
| after 18 weeks of treatment |
| Blood glucose | after 18 weeks of treatment |
| Hypoglycaemia | after 18 weeks of treatment |
| Buenos Aires |
| C1425AGC |
| Argentina |
| Novo Nordisk Investigational Site | Mar del Plata | B7600FZN | Argentina |
| Novo Nordisk Investigational Site | Mendoza | 5500 | Argentina |
| Novo Nordisk Investigational Site | Ebreichsdorf | 2483 | Austria |
| Novo Nordisk Investigational Site | Kittsee | A 2421 | Austria |
| Novo Nordisk Investigational Site | Salzburg | 5020 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1130 | Austria |
| Novo Nordisk Investigational Site | Vienna | A 1160 | Austria |
| Novo Nordisk Investigational Site | Arlon | 6700 | Belgium |
| Novo Nordisk Investigational Site | Bonheiden | 2820 | Belgium |
| Novo Nordisk Investigational Site | Borsbeek | 2150 | Belgium |
| Novo Nordisk Investigational Site | Ghent | 9000 | Belgium |
| Novo Nordisk Investigational Site | Huy | 4500 | Belgium |
| Novo Nordisk Investigational Site | Leuven | 3000 | Belgium |
| Novo Nordisk Investigational Site | Sofia | 1431 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1606 | Bulgaria |
| Novo Nordisk Investigational Site | Edmonton | Alberta | T5J 3N4 | Canada |
| Novo Nordisk Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Novo Nordisk Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Novo Nordisk Investigational Site | Hamilton | Ontario | L8L 2X2 | Canada |
| Novo Nordisk Investigational Site | Smiths Falls | Ontario | K7A 4W8 | Canada |
| Novo Nordisk Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| Novo Nordisk Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Novo Nordisk Investigational Site | Mississauga | L5M 2V8 | Canada |
| Novo Nordisk Investigational Site | Oshawa | L1J 2K1 | Canada |
| Novo Nordisk Investigational Site | Saskatoon | S7N 0W8 | Canada |
| Novo Nordisk Investigational Site | Trois-Rivières | G8T 7A1 | Canada |
| Novo Nordisk Investigational Site | Corbeil-Essonnes | 91106 | France |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Paris | 75877 | France |
| Novo Nordisk Investigational Site | Roubaix | 59100 | France |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | 452010 | India |
| Novo Nordisk Investigational Site | Bangalore | 560041 | India |
| Novo Nordisk Investigational Site | Coimbatore | 641002 | India |
| Novo Nordisk Investigational Site | Hyderabad | 600034 | India |
| Novo Nordisk Investigational Site | Thriruvananthapuram | 695 032 | India |
| Novo Nordisk Investigational Site | Beersheba | 84101 | Israel |
| Novo Nordisk Investigational Site | Holon | 58100 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 91120 | Israel |
| Novo Nordisk Investigational Site | Mexico City | México, D.F. | 14000 | Mexico |
| Novo Nordisk Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Novo Nordisk Investigational Site | Guadalajara | 44600 | Mexico |
| Novo Nordisk Investigational Site | Mexico City | 03100 | Mexico |
| Novo Nordisk Investigational Site | Mexico City | 11650 | Mexico |
| Novo Nordisk Investigational Site | Gdansk | 80-858 | Poland |
| Novo Nordisk Investigational Site | Lodz | 90-030 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-044 | Poland |
| Novo Nordisk Investigational Site | Lublin | 20-538 | Poland |
| Novo Nordisk Investigational Site | Mazowieckie | 09-400 | Poland |
| Novo Nordisk Investigational Site | Rawa Mazowiecka | 96-200 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-097 | Poland |
| Novo Nordisk Investigational Site | Zabrze | 41-800 | Poland |
| Novo Nordisk Investigational Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34371 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34718 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Konya | 42001 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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