Clinical trial NCT00134147: A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2005-08-24
Enrollment: 1100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 2
* Failing two or more oral anti-diabetic agents

Exclusion Criteria:

* Asthma, COPD
* Smoking

Primary outcomes:
measure: Glycosylated hemoglobin
Secondary outcomes:
measure: Percent of patients achieving good control of fasting glucose and lipids
measure: Rate of hypoglycemia
measure: Changes in body weight
measure: Patient satisfaction
measure: Safety based on adverse events reported and laboratory tests
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Smith Falls
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Bethune CEDEX
country: France
facility: Pfizer Investigational Site
city: Bourg En Bresse
country: France
facility: Pfizer Investigational Site
city: Bron
country: France
facility: Pfizer Investigational Site
city: Corbeil Essonnes Cedex
country: France
facility: Pfizer Investigational Site
city: La Rochelle Cedex
country: France
facility: Pfizer Investigational Site
city: Montpellier CEDEX
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Roubaix
country: France
facility: Pfizer Investigational Site
city: TOURS cedex 7
country: France
facility: Pfizer Investigational Site
city: Altenburg
country: Germany
facility: Pfizer Investigational Site
city: Aschaffenburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Oeynhausen/ Volmerdingen
country: Germany
facility: Pfizer Investigational Site
city: Bad-Mergentheim
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Delmenhorst
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Ebersdorf
country: Germany
facility: Pfizer Investigational Site
city: Eisenach
country: Germany
facility: Pfizer Investigational Site
city: Falkensee
country: Germany
facility: Pfizer Investigational Site
city: Furth im Wald
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hassloch
country: Germany
facility: Pfizer Investigational Site
city: Kuenzing
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Meissen
country: Germany
facility: Pfizer Investigational Site
city: Mittweida
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Offenbach
country: Germany
facility: Pfizer Investigational Site
city: Offenburg
country: Germany
facility: Pfizer Investigational Site
city: Oschatz
country: Germany
facility: Pfizer Investigational Site
city: Pirna
country: Germany
facility: Pfizer Investigational Site
city: Riedlhuette
country: Germany
facility: Pfizer Investigational Site
city: Riesa
country: Germany
facility: Pfizer Investigational Site
city: Rossach
country: Germany
facility: Pfizer Investigational Site
city: Schwabenheim
country: Germany
facility: Pfizer Investigational Site
city: St.Ingbert
country: Germany
facility: Pfizer Investigational Site
city: Surwold
country: Germany
facility: Pfizer Investigational Site
city: Wangen / Allgaeu
country: Germany
facility: Pfizer Investigational Site
city: Wangen
country: Germany
facility: Pfizer Investigational Site
city: Witten
country: Germany
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Pescara
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Verona
country: Italy
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Las Palmas
country: Spain
facility: Pfizer Investigational Site
state: Las Palmas de Gran Canaria
city: Baracaldo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Ayr
country: United Kingdom
facility: Pfizer Investigational Site
state: Ayrshire
city: Thornhill
country: United Kingdom
facility: Pfizer Investigational Site
state: Cardiff
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: St. Austell
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Letchworth
country: United Kingdom
facility: Pfizer Investigational Site
state: Hertfordshire
city: Sidcup
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Whitstable
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Colney
country: United Kingdom
facility: Pfizer Investigational Site
state: Norwich
city: Headington
country: United Kingdom
facility: Pfizer Investigational Site
state: Oxford
city: Penarth
country: United Kingdom
facility: Pfizer Investigational Site
state: South Glamorgan
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
state: Tayside
city: Haywards Heath
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
city: Canterbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Salford
country: United Kingdom
facility: Pfizer Investigational Site
city: York
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.