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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000796-15 | EudraCT Number |
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See termination reason in detailed description
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This trial is conducted in Europe.
The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (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 | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone | Drug | Tablets, 4 mg once or twice daily. |
| |
| inhaled human insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment difference in HbA1c | After 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | For the duration of the trial | |
| Body weight | For the duration of the trial | |
| 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 | Ebreichsdorf | 2483 | Austria | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Drug |
Treat-to-target dose titration scheme, inhalation. |
|
|
| metformin | Drug | Tablets, 2000 mg/day. |
|
| For the duration of the trial |
| Blood glucose | For the duration of the trial |
| Hypoglycaemia | For the duration of the trial |
| Vienna |
| 1030 |
| Austria |
| Novo Nordisk Investigational Site | Vienna | 1090 | Austria |
| Novo Nordisk Investigational Site | Joensuu | 80130 | Finland |
| Novo Nordisk Investigational Site | Kirkkonummi | 02400 | Finland |
| Novo Nordisk Investigational Site | Turku | FI-20520 | Finland |
| Novo Nordisk Investigational Site | Corbeil-Essonnes | 91106 | France |
| Novo Nordisk Investigational Site | La Rochelle | 17019 | France |
| Novo Nordisk Investigational Site | Mougins | 06250 | France |
| Novo Nordisk Investigational Site | Nanterre | 92014 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Pessac | 33600 | France |
| Novo Nordisk Investigational Site | Pointe à Pitre | 97159 | France |
| Novo Nordisk Investigational Site | Roubaix | 59100 | France |
| Novo Nordisk Investigational Site | Tours | 37044 | France |
| Novo Nordisk Investigational Site | Vénissieux | 69200 | France |
| Novo Nordisk Investigational Site | Aschaffenburg | 63739 | Germany |
| Novo Nordisk Investigational Site | Augsburg | 86150 | Germany |
| Novo Nordisk Investigational Site | Bad Mergentheim | 97980 | Germany |
| Novo Nordisk Investigational Site | Berlin | 13355 | Germany |
| Novo Nordisk Investigational Site | Darmstadt | 64283 | Germany |
| Novo Nordisk Investigational Site | Dormagen | 41539 | Germany |
| Novo Nordisk Investigational Site | Dresden | 01307 | Germany |
| Novo Nordisk Investigational Site | Duisburg | 47051 | Germany |
| Novo Nordisk Investigational Site | Flörsheim | 65439 | Germany |
| Novo Nordisk Investigational Site | Frankfurt | 60590 | Germany |
| Novo Nordisk Investigational Site | Fulda | 36037 | Germany |
| Novo Nordisk Investigational Site | Genthin | 39307 | Germany |
| Novo Nordisk Investigational Site | Hermaringen | 89568 | Germany |
| Novo Nordisk Investigational Site | Kutenholz-Mulsum | 27449 | Germany |
| Novo Nordisk Investigational Site | Münster | 48145 | Germany |
| Novo Nordisk Investigational Site | Pirna | 01796 | Germany |
| Novo Nordisk Investigational Site | Schkeuditz | 04435 | Germany |
| Novo Nordisk Investigational Site | Wangen | 88239 | Germany |
| Novo Nordisk Investigational Site | Wiesbaden | 65191 | Germany |
| Novo Nordisk Investigational Site | Dublin | DUBLIN 7 | Ireland |
| Novo Nordisk Investigational Site | Dublin | DUBLIN 8 | Ireland |
| Novo Nordisk Investigational Site | Waterford | Ireland |
| Novo Nordisk Investigational Site | Delft | 2625 AD | Netherlands |
| Novo Nordisk Investigational Site | Drachten | 9202 NN | Netherlands |
| Novo Nordisk Investigational Site | Rijswijk | 2281 AK | Netherlands |
| Novo Nordisk Investigational Site | Roelofarendsveen | 2371 RB | Netherlands |
| Novo Nordisk Investigational Site | The Hague | 2582 LJ | Netherlands |
| Novo Nordisk Investigational Site | The Hague | 2597 AX | Netherlands |
| Novo Nordisk Investigational Site | Vlodrop | 6063 DA | Netherlands |
| Novo Nordisk Investigational Site | Zwijndrecht | 3331 LZ | Netherlands |
| Novo Nordisk Investigational Site | Alzira | 46600 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Gijón | 33206 | Spain |
| Novo Nordisk Investigational Site | Majadahonda | 28222 | Spain |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07010 | Spain |
| Novo Nordisk Investigational Site | Partida de Bacarot | 03114 | Spain |
| Novo Nordisk Investigational Site | Pontevedra | 36071 | Spain |
| Novo Nordisk Investigational Site | Reus | 43201 | Spain |
| Novo Nordisk Investigational Site | San Juan | 03550 | Spain |
| Novo Nordisk Investigational Site | Seville | 41009 | Spain |
| Novo Nordisk Investigational Site | Interlaken-Unterseen | 3800 | Switzerland |
| Novo Nordisk Investigational Site | Olten | 4600 | Switzerland |
| Novo Nordisk Investigational Site | Zurich | 8032 | Switzerland |
| Novo Nordisk Investigational Site | Aberdeen | AB25 1LD | United Kingdom |
| Novo Nordisk Investigational Site | Bath | BA1 2SR | United Kingdom |
| Novo Nordisk Investigational Site | Belfast | BT12 6BA | United Kingdom |
| Novo Nordisk Investigational Site | Birmingham | B9 5SS | United Kingdom |
| Novo Nordisk Investigational Site | Bradford-on-Avon | BA15 1DQ | United Kingdom |
| Novo Nordisk Investigational Site | Guildford | GU2 7XX | United Kingdom |
| Novo Nordisk Investigational Site | Hull | HU3 2JZ | United Kingdom |
| Novo Nordisk Investigational Site | Northampton | NN1 5BD | United Kingdom |
| Novo Nordisk Investigational Site | Salford | M6 8HD | United Kingdom |
| Novo Nordisk Investigational Site | Swansea | SA6 6NL | United Kingdom |
| Novo Nordisk Investigational Site | Trowbridge | BA14 8QA | United Kingdom |
| Novo Nordisk Investigational Site | Trowbridge | BA14 9AR | United Kingdom |
| Novo Nordisk Investigational Site | Wirral, Merseyside | CH63 4JY | United Kingdom |
| Novo Nordisk Investigational Site | York | YO3 7HE | United Kingdom |
| 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 |
|---|---|
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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