Diabetes Mellitus Clinical Trial
Official title:
A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents
| Verified date | April 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
| Status | Completed |
| Enrollment | 1100 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Diabetes mellitus Type 2 - Failing two or more oral anti-diabetic agents Exclusion Criteria: - Asthma, COPD - Smoking |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Charlottetown | Prince Edward Island |
| Canada | Pfizer Investigational Site | Corunna | Ontario |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Oakville | Ontario |
| Canada | Pfizer Investigational Site | Red Deer | Alberta |
| Canada | Pfizer Investigational Site | Smith Falls | Ontario |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| France | Pfizer Investigational Site | Bethune CEDEX | |
| France | Pfizer Investigational Site | Bourg En Bresse | |
| France | Pfizer Investigational Site | Bron | |
| France | Pfizer Investigational Site | Corbeil Essonnes Cedex | |
| France | Pfizer Investigational Site | La Rochelle Cedex | |
| France | Pfizer Investigational Site | Montpellier CEDEX | |
| France | Pfizer Investigational Site | Nantes | |
| France | Pfizer Investigational Site | Roubaix | |
| France | Pfizer Investigational Site | TOURS cedex 7 | |
| Germany | Pfizer Investigational Site | Altenburg | |
| Germany | Pfizer Investigational Site | Aschaffenburg | |
| Germany | Pfizer Investigational Site | Bad Oeynhausen/ Volmerdingen | |
| Germany | Pfizer Investigational Site | Bad-Mergentheim | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Delmenhorst | |
| Germany | Pfizer Investigational Site | Dresden | |
| Germany | Pfizer Investigational Site | Ebersdorf | |
| Germany | Pfizer Investigational Site | Eisenach | |
| Germany | Pfizer Investigational Site | Falkensee | |
| Germany | Pfizer Investigational Site | Furth im Wald | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Hassloch | |
| Germany | Pfizer Investigational Site | Kuenzing | |
| Germany | Pfizer Investigational Site | Leipzig | |
| Germany | Pfizer Investigational Site | Meissen | |
| Germany | Pfizer Investigational Site | Mittweida | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | Offenbach | |
| Germany | Pfizer Investigational Site | Offenburg | |
| Germany | Pfizer Investigational Site | Oschatz | |
| Germany | Pfizer Investigational Site | Pirna | |
| Germany | Pfizer Investigational Site | Riedlhuette | |
| Germany | Pfizer Investigational Site | Riesa | |
| Germany | Pfizer Investigational Site | Rossach | |
| Germany | Pfizer Investigational Site | Schwabenheim | |
| Germany | Pfizer Investigational Site | St.Ingbert | |
| Germany | Pfizer Investigational Site | Surwold | |
| Germany | Pfizer Investigational Site | Wangen | |
| Germany | Pfizer Investigational Site | Wangen / Allgaeu | |
| Germany | Pfizer Investigational Site | Witten | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Padova | |
| Italy | Pfizer Investigational Site | Palermo | |
| Italy | Pfizer Investigational Site | Pescara | |
| Italy | Pfizer Investigational Site | Pisa | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Udine | |
| Italy | Pfizer Investigational Site | Verona | |
| Spain | Pfizer Investigational Site | Badalona | Barcelona |
| Spain | Pfizer Investigational Site | Baracaldo | Vizcaya |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Bilbao | Vizcaya |
| Spain | Pfizer Investigational Site | Cadiz | |
| Spain | Pfizer Investigational Site | Gerona | |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Las Palmas | Las Palmas de Gran Canaria |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| United Kingdom | Pfizer Investigational Site | Ayr | Ayrshire |
| United Kingdom | Pfizer Investigational Site | Birmingham | |
| United Kingdom | Pfizer Investigational Site | Blackpool | Lancashire |
| United Kingdom | Pfizer Investigational Site | Bolton | |
| United Kingdom | Pfizer Investigational Site | Canterbury | |
| United Kingdom | Pfizer Investigational Site | Colney | Norwich |
| United Kingdom | Pfizer Investigational Site | Dundee | Tayside |
| United Kingdom | Pfizer Investigational Site | Haywards Heath | West Sussex |
| United Kingdom | Pfizer Investigational Site | Headington | Oxford |
| United Kingdom | Pfizer Investigational Site | Letchworth | Hertfordshire |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | Penarth | South Glamorgan |
| United Kingdom | Pfizer Investigational Site | Penzance | Cornwall |
| United Kingdom | Pfizer Investigational Site | Plymouth | Devon |
| United Kingdom | Pfizer Investigational Site | Salford | |
| United Kingdom | Pfizer Investigational Site | Sidcup | Kent |
| United Kingdom | Pfizer Investigational Site | St. Austell | Cornwall |
| United Kingdom | Pfizer Investigational Site | Thornhill | Cardiff |
| United Kingdom | Pfizer Investigational Site | Truro | Cornwall |
| United Kingdom | Pfizer Investigational Site | Whitstable | Kent |
| United Kingdom | Pfizer Investigational Site | York | |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Columbus | Georgia |
| United States | Pfizer Investigational Site | Hershey | Pennsylvania |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Medford | Oregon |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Sanofi |
United States, Canada, France, Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glycosylated hemoglobin | |||
| Secondary | Percent of patients achieving good control of fasting glucose and lipids | |||
| Secondary | Rate of hypoglycemia | |||
| Secondary | Changes in body weight | |||
| Secondary | Patient satisfaction | |||
| Secondary | Safety based on adverse events reported and laboratory tests |
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