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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00150410




Registration number
NCT00150410
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
31/10/2008

Titles & IDs
Public title
Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
Scientific title
A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment
Secondary ID [1] 0 0
A2171017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inhaled insulin

Treatment: Drugs: Inhaled insulin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycosylated hemoglobin
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change from baseline in fasting plasma glucose. Other secondary efficacy
Timepoint [1] 0 0
Secondary outcome [2] 0 0
endpoints include, body weight, patient reported outcomes, incidence and severity
Timepoint [2] 0 0
Secondary outcome [3] 0 0
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
Timepoint [3] 0 0
Secondary outcome [4] 0 0
insufficient clinical response.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Type 2 diabetes

- Currently treated and on a stable doses of drugs for the preceding two (2) months
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 Diabetes

- Smoking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
626
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woolloongabba
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Keswick
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Caulfield
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5035 - Keswick
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3162 - Caulfield
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Brazil
State/province [38] 0 0
RS
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Brazil
State/province [39] 0 0
SP
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Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
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Ontario
Country [42] 0 0
Canada
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Quebec
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Canada
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St. John's
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Mexico
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DF
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Mexico
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Jalisco/Mexico
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Veracruz
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Mexico
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Mexico Df

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an
investigational drug, controls your diabetes at least as much as a triple combination
therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration
(FDA) approved drug.

- Whether a combination of two therapies - metformin plus Exubera controls your diabetes
at least as much as a as a triple combination therapy of metformin and a sulfonylurea
plus Avandia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00150410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries