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See termination reason in detailed description
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This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride 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 | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone | Drug | Tablets, 4 mg once or twice a day. |
| |
| 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 | during 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 | St Leonards | New South Wales | 2065 | Australia | ||
| 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, pre-prandial, inhalation. |
|
|
| glimepiride | Drug | Tablets, 4 mg/day. |
|
| after 26 weeks of treatment |
| Blood glucose | after 26 weeks of treatment |
| Hypoglycaemia | from 12-26 weeks of treatment |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Novo Nordisk Investigational Site | Garran | 2605 | Australia |
| Novo Nordisk Investigational Site | Kingswood | 2747 | Australia |
| Novo Nordisk Investigational Site | Osijek | 31 000 | Croatia |
| Novo Nordisk Investigational Site | Zagreb | 10 000 | Croatia |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600086 | India |
| Novo Nordisk Investigational Site | Vellore | Tamil Nadu | 632004 | India |
| Novo Nordisk Investigational Site | Bangalore | 560010 | India |
| Novo Nordisk Investigational Site | Chennai | 600020 | India |
| Novo Nordisk Investigational Site | Coimbatore | 641002 | India |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Cebu City | 6000 | Philippines |
| Novo Nordisk Investigational Site | Makati City | 1200 | Philippines |
| Novo Nordisk Investigational Site | Manila | 1000 | Philippines |
| Novo Nordisk Investigational Site | Moscow | 119034 | Russia |
| Novo Nordisk Investigational Site | Moscow | 121356 | Russia |
| Novo Nordisk Investigational Site | Moscow | 127486 | Russia |
| Novo Nordisk Investigational Site | Moscow | 127644 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194354 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 198013 | Russia |
| Novo Nordisk Investigational Site | Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Bursa | 16059 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34390 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34718 | 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 |
|---|---|
| D000077154 | Rosiglitazone |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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