Not provided
Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 and pioglitazone combination therapy versus pioglitazone treatment alone.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | Tablets, 45 mg/day. |
| |
| inhaled human insulin |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change from baseline | After 26 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | after 26 weeks of treatment | |
| Lipid profiles | after 26 weeks of treatment | |
| Frequency of hypoglycaemic episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Ozark | Alabama | 36360 | United States | ||
| Novo Nordisk Investigational Site |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Treat-to-target dose titration scheme, inhalation. |
|
|
| after 26 weeks of treatment |
| Glucose profiles | at pre- and post meals, bedtime and 3:00 am |
| Change in body weight | after 26 weeks of treatment |
| 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 | Little Rock | Arkansas | 72204 | United States |
| Novo Nordisk Investigational Site | Bermuda Dunes | California | 92203 | 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 | Northridge | California | 91325 | United States |
| Novo Nordisk Investigational Site | Orange | California | 92868 | 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 | 92103-620 | 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 | Tustin | California | 92780 | United States |
| Novo Nordisk Investigational Site | Walnut Creek | California | 94598 | United States |
| Novo Nordisk Investigational Site | Arvada | Colorado | 80005 | United States |
| Novo Nordisk Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| Novo Nordisk Investigational Site | Beverly Hills | Florida | 34465 | 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 | Miami | Florida | 33136 | United States |
| Novo Nordisk Investigational Site | Niceville | Florida | 32578 | United States |
| Novo Nordisk Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Novo Nordisk Investigational Site | Panama City | Florida | 32401 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33029 | United States |
| Novo Nordisk Investigational Site | St. Petersburg | Florida | 33709 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | 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 | 30342 | United States |
| Novo Nordisk Investigational Site | Blue Ridge | Georgia | 30513 | 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 | Sandy Springs | Georgia | 30328 | 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 | Avon | Illinois | 46123 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60611 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60612 | United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61615 | 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 | 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 | Baltimore | Maryland | 21201 | United States |
| Novo Nordisk Investigational Site | Prince Frederick | Maryland | 20678 | United States |
| Novo Nordisk Investigational Site | Marlborough | Massachusetts | 01752 | United States |
| Novo Nordisk Investigational Site | Waltham | Massachusetts | 02453 | United States |
| Novo Nordisk Investigational Site | Bloomington | Minnesota | 55420 | 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 | 59102 | United States |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Novo Nordisk Investigational Site | Syracuse | New York | 13210 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Novo Nordisk Investigational Site | High Point | North Carolina | 27262 | United States |
| Novo Nordisk Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Novo Nordisk Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Novo Nordisk Investigational Site | Bismarck | North Dakota | 58501 | United States |
| Novo Nordisk Investigational Site | Canal Fulton | Ohio | 44614 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45224 | 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 | 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 | Bensalem | Pennsylvania | 19020 | United States |
| Novo Nordisk Investigational Site | Hershey | Pennsylvania | 17033 | 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 | 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 | 75251 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77024 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Lewisville | Texas | 75067 | United States |
| Novo Nordisk Investigational Site | Plano | Texas | 75093 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | United States |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | 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 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided