Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
Wisconsin
Country [38] 0 0
Brazil
State/province [38] 0 0
RS
Country [39] 0 0
Brazil
State/province [39] 0 0
SP
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
St. John's
Country [44] 0 0
Mexico
State/province [44] 0 0
DF
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco/Mexico
Country [46] 0 0
Mexico
State/province [46] 0 0
Jalisco
Country [47] 0 0
Mexico
State/province [47] 0 0
Nuevo Leon
Country [48] 0 0
Mexico
State/province [48] 0 0
Veracruz
Country [49] 0 0
Mexico
State/province [49] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00150410