Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
| Verified date | September 2018 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 196 |
| Est. completion date | March 18, 2008 |
| Est. primary completion date | March 18, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Current treatment with oral antidiabetes drugs (OADs) for at least 2 months - HbA1c between 7.0-11.0% if on OAD monotherapy - HbA1c between 7.0-10.0% if on OAD combination therapy - BMI less than or equal to 40 kg/m2 Exclusion Criteria: - Current regular smoking or regular smoking within the last 6 months - Current acute or chronic pulmonary disease (except for asthma) - Proliferative retinopathy requiring treatment - Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Altoona | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Arlington | Virginia |
| United States | Novo Nordisk Investigational Site | Arvada | Colorado |
| United States | Novo Nordisk Investigational Site | Athens | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Avon | Illinois |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Beaver | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Bensalem | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Bermuda Dunes | California |
| United States | Novo Nordisk Investigational Site | Beverly Hills | Florida |
| United States | Novo Nordisk Investigational Site | Billings | Montana |
| United States | Novo Nordisk Investigational Site | Bismarck | North Dakota |
| United States | Novo Nordisk Investigational Site | Bloomington | Minnesota |
| United States | Novo Nordisk Investigational Site | Blue Ridge | Georgia |
| United States | Novo Nordisk Investigational Site | Boca Raton | Florida |
| United States | Novo Nordisk Investigational Site | Boise | Idaho |
| United States | Novo Nordisk Investigational Site | Canal Fulton | Ohio |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Clarksville | Tennessee |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Clinton | Oklahoma |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Des Moines | Iowa |
| United States | Novo Nordisk Investigational Site | Dunwoody | Georgia |
| United States | Novo Nordisk Investigational Site | Escondido | California |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Hershey | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| United States | Novo Nordisk Investigational Site | High Point | North Carolina |
| United States | Novo Nordisk Investigational Site | Hollywood | Florida |
| United States | Novo Nordisk Investigational Site | Honolulu | Hawaii |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Huntington Beach | California |
| United States | Novo Nordisk Investigational Site | Jackson | Mississippi |
| United States | Novo Nordisk Investigational Site | Jefferson City | Missouri |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Kingsport | Tennessee |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | Lafayette | Indiana |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lewisville | Texas |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Marianna | Florida |
| United States | Novo Nordisk Investigational Site | Marlborough | Massachusetts |
| United States | Novo Nordisk Investigational Site | Medford | Oregon |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Niceville | Florida |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | Norristown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Ozark | Alabama |
| United States | Novo Nordisk Investigational Site | Palm Harbor | Florida |
| United States | Novo Nordisk Investigational Site | Panama City | Florida |
| United States | Novo Nordisk Investigational Site | Pembroke Pines | Florida |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Poway | California |
| United States | Novo Nordisk Investigational Site | Powder Springs | Georgia |
| United States | Novo Nordisk Investigational Site | Prince Frederick | Maryland |
| United States | Novo Nordisk Investigational Site | Raleigh | North Carolina |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Roseville | California |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Sacramento | California |
| United States | Novo Nordisk Investigational Site | Saint George | Utah |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Saint Petersburg | Florida |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Sandy Springs | Georgia |
| United States | Novo Nordisk Investigational Site | Santa Barbara | California |
| United States | Novo Nordisk Investigational Site | Suwanee | Georgia |
| United States | Novo Nordisk Investigational Site | Syracuse | New York |
| United States | Novo Nordisk Investigational Site | Tacoma | Washington |
| United States | Novo Nordisk Investigational Site | Tallahassee | Florida |
| United States | Novo Nordisk Investigational Site | Temecula | California |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tucker | Georgia |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tuscaloosa | Alabama |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | Vero Beach | Florida |
| United States | Novo Nordisk Investigational Site | Vestavia Hills | Alabama |
| United States | Novo Nordisk Investigational Site | Walnut Creek | California |
| United States | Novo Nordisk Investigational Site | Waltham | Massachusetts |
| United States | Novo Nordisk Investigational Site | Warrenton | Virginia |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| United States | Novo Nordisk Investigational Site | Wichita | Kansas |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c change from baseline | After 26 weeks of treatment | ||
| Secondary | Fasting plasma glucose | after 26 weeks of treatment | ||
| Secondary | Lipid profiles | after 26 weeks of treatment | ||
| Secondary | Frequency of hypoglycaemic episodes | after 26 weeks of treatment | ||
| Secondary | Glucose profiles | at pre- and post meals, bedtime and 3:00 am | ||
| Secondary | Change in body weight | after 26 weeks of treatment |
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