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See termination reason in detailed description
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This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride.
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 |
|---|---|---|
| Change in HbA1c | After 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | For the duration of the trial | |
| Lipid profiles | For the duration of the trial | |
| Hypoglycaemic episodes |
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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 | Hueytown | Alabama | 35023 | United States | ||
| 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. |
|
| glimepiride | Drug | Tablets, 8 mg/day. |
|
| For the duration of the trial |
| Glucose profiles | For the duration of the trial |
| Change in body weight | For the duration of the trial |
| Ozark |
| Alabama |
| 36360 |
| United States |
| Novo Nordisk Investigational Site | Tuscaloosa | Alabama | 35406 | United States |
| Novo Nordisk Investigational Site | Vestavia Hills | Alabama | 35209 | United States |
| Novo Nordisk Investigational Site | Tucson | Arizona | 85741 | United States |
| Novo Nordisk Investigational Site | Concord | California | 94520 | United States |
| Novo Nordisk Investigational Site | Escondido | California | 92025 | United States |
| Novo Nordisk Investigational Site | Fresno | California | 93720 | United States |
| Novo Nordisk Investigational Site | Huntington Beach | California | 92646 | United States |
| Novo Nordisk Investigational Site | La Jolla | California | 92037 | United States |
| Novo Nordisk Investigational Site | Orange | California | 92869 | United States |
| Novo Nordisk Investigational Site | Poway | California | 92064 | United States |
| Novo Nordisk Investigational Site | Roseville | California | 95661 | United States |
| Novo Nordisk Investigational Site | Sacramento | California | 95821 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92103 | United States |
| Novo Nordisk Investigational Site | Santa Barbara | California | 93105 | United States |
| Novo Nordisk Investigational Site | Temecula | California | 92591 | United States |
| Novo Nordisk Investigational Site | Walnut Creek | California | 94598 | United States |
| Novo Nordisk Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| Novo Nordisk Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Novo Nordisk Investigational Site | Boca Raton | Florida | 33433 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33759 | United States |
| Novo Nordisk Investigational Site | Hialeah | Florida | 33010 | United States |
| Novo Nordisk Investigational Site | Hollywood | Florida | 33021 | United States |
| Novo Nordisk Investigational Site | Lake Mary | Florida | 32746 | United States |
| Novo Nordisk Investigational Site | Marianna | Florida | 32446 | United States |
| Novo Nordisk Investigational Site | Melbourne | Florida | 32901 | United States |
| Novo Nordisk Investigational Site | Merritt Island | Florida | 32953 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | United States |
| Novo Nordisk Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33029 | United States |
| Novo Nordisk Investigational Site | Vero Beach | Florida | 32960 | United States |
| Novo Nordisk Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Novo Nordisk Investigational Site | Athens | Georgia | 30606 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30342 | United States |
| Novo Nordisk Investigational Site | Augusta | Georgia | 30912-3152 | United States |
| Novo Nordisk Investigational Site | Dunwoody | Georgia | 30338 | United States |
| Novo Nordisk Investigational Site | Powder Springs | Georgia | 30127 | United States |
| Novo Nordisk Investigational Site | Roswell | Georgia | 30076 | United States |
| Novo Nordisk Investigational Site | Suwanee | Georgia | 30024 | United States |
| Novo Nordisk Investigational Site | Tucker | Georgia | 30084 | United States |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Novo Nordisk Investigational Site | Boise | Idaho | 83702 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61615 | United States |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62711 | United States |
| Novo Nordisk Investigational Site | Lafayette | Indiana | 47904 | United States |
| Novo Nordisk Investigational Site | Des Moines | Iowa | 50314 | United States |
| Novo Nordisk Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| Novo Nordisk Investigational Site | Topeka | Kansas | 66606 | United States |
| Novo Nordisk Investigational Site | Wichita | Kansas | 67205 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | United States |
| Novo Nordisk Investigational Site | Scarborough | Maine | 04074 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21201 | United States |
| Novo Nordisk Investigational Site | Marlborough | Massachusetts | 01752 | United States |
| Novo Nordisk Investigational Site | Springfield | Massachusetts | 01199 | United States |
| Novo Nordisk Investigational Site | Jackson | Mississippi | 39216 | United States |
| Novo Nordisk Investigational Site | Chesterfield | Missouri | 63017 | United States |
| Novo Nordisk Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64111 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63141 | United States |
| Novo Nordisk Investigational Site | Billings | Montana | 59101 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68114 | United States |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Novo Nordisk Investigational Site | Berlin | New Jersey | 08009 | United States |
| Novo Nordisk Investigational Site | Cherry Hill | New Jersey | 08034 | United States |
| Novo Nordisk Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Novo Nordisk Investigational Site | Staten Island | New York | 10301 | United States |
| Novo Nordisk Investigational Site | Syracuse | New York | 13210 | United States |
| Novo Nordisk Investigational Site | Asheville | North Carolina | 28803 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Novo Nordisk Investigational Site | Greenville | North Carolina | 27834 | United States |
| Novo Nordisk Investigational Site | High Point | North Carolina | 27262 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44115 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44122 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45406 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45439 | United States |
| Novo Nordisk Investigational Site | Clinton | Oklahoma | 73601 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73104-5020 | United States |
| Novo Nordisk Investigational Site | Medford | Oregon | 97504-8491 | United States |
| Novo Nordisk Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Novo Nordisk Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| Novo Nordisk Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37411 | United States |
| Novo Nordisk Investigational Site | Clarksville | Tennessee | 37043 | United States |
| Novo Nordisk Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Novo Nordisk Investigational Site | Arlington | Texas | 76014 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75231 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Hurst | Texas | 76054 | United States |
| Novo Nordisk Investigational Site | Lewisville | Texas | 75067 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | United States |
| Novo Nordisk Investigational Site | Arlington | Virginia | 22204 | United States |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23502 | United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23249 | United States |
| Novo Nordisk Investigational Site | Warrenton | Virginia | 20186 | United States |
| Novo Nordisk Investigational Site | Renton | Washington | 98057 | United States |
| Novo Nordisk Investigational Site | Tacoma | Washington | 98405 | United States |
| 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 |
| C057619 | glimepiride |
| 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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