Diabetes MellitusPhase 3NCT00150410
Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
A Phase 3 study testing Inhaled insulin in people with Diabetes Mellitus, run by Pfizer at 119 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Inhaled insulin
- How many people
- 626 participants
- Where
- 119 sitesin 5 countries
- Study dates
- Jan 2003to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Currently treated and on a stable doses of drugs for the preceding two (2) months
Who cannot join
- Type 1 Diabetes
- Smoking
Trial locations and contacts
119 sites in 5 countries.
119 sites in 5 countries
United States88 sites
Pfizer Investigational Site
‘Ewa Beach, Hawaii, 96706
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Alhambra, California, 91801
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Charleston, South Carolina, 29401-5799
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chicago Heights, Illinois, 60411
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Concord, California, 94520
Pfizer Investigational Site
Corpus Christi, Texas, 78411
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Des Moines, Iowa, 50314
Pfizer Investigational Site
Duncan, South Carolina, 29334
Pfizer Investigational Site
El Paso, Texas, 79925
Pfizer Investigational Site
El Paso, Texas, 79935
Pfizer Investigational Site
Flushing, New York, 11365
Pfizer Investigational Site
Fredericksburg, Virginia, 22401
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Huntington Beach, California, 92647
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Idaho Falls, Idaho, 83404-6370
Pfizer Investigational Site
Idaho Falls, Idaho, 83404-7542
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Knoxville, Tennessee, 37909
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Lakewood, Ohio, 44107
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Lincoln, Nebraska, 68521
Pfizer Investigational Site
Long Beach, California, 90805
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Mesa, Arizona, 85205
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New Hyde Park, New York, 11042
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
North Kansas City, Missouri, 64116
Pfizer Investigational Site
Ogden, Utah, 84403
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Phoenix, Arizona, 85012
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15235
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Richmond, Virginia, 23221
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78237
Pfizer Investigational Site
Santa Barbara, California, 93105
Pfizer Investigational Site
Savannah, Georgia, 31405
Pfizer Investigational Site
Savannah, Georgia, 31419
Pfizer Investigational Site
Searcy, Arkansas, 72143
Pfizer Investigational Site
Spartanburg, South Carolina, 29303
Pfizer Investigational Site
Spartanburg, South Carolina, 29307
Pfizer Investigational Site
Springfield, Massachusetts, 01103
Pfizer Investigational Site
Springfield, Massachusetts, 01199
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Sumter, South Carolina, 29150
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Tukwila, Washington, 98188
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Waltham, Massachusetts, 02453
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Washington D.C., District of Columbia, 20307
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
West Saint Paul, Minnesota, 55118
Pfizer Investigational Site
Westminster, California, 92683
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Wichita, Kansas, 67203
Pfizer Investigational Site
Winter Park, Florida, 32789
Canada12 sites
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Mississauga, Ontario, L5M2V8
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Saint-Jérôme, Quebec, J7Z 5T3
Pfizer Investigational Site
St. John's, A1E 2E2
Pfizer Investigational Site
Thornhill, Ontario, L4J 1V8
Pfizer Investigational Site
Toronto, Ontario, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, M4R 2G4
Pfizer Investigational Site
Vaudreuil, Quebec, J7V 8P9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
Mexico9 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44340
Pfizer Investigational Site
Guadalajara, Jalisco, 44349
Pfizer Investigational Site
Guadalajara, Jalisco, 44660
Pfizer Investigational Site
Guadalajara, Jalisco/Mexico, 44347
Pfizer Investigational Site
Jalapa, Veracruz, 91020
Pfizer Investigational Site
Mexico City, Mexico City, 02990
Pfizer Investigational Site
Mexico City, Mexico City, 03100
Pfizer Investigational Site
Mexico City, CP 14000
Pfizer Investigational Site
Monterrey, Nuevo León, 64060
Australia7 sites
Pfizer Investigational Site
Box Hill, Victoria, 3128
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Caulfield, Victoria, 3162
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Keswick, South Australia, 5035
Pfizer Investigational Site
Wollongong, New South Wales, 2500
Pfizer Investigational Site
Woolloongabba, Queensland, 4102
Brazil3 sites
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Pfizer Investigational Site
São Paulo, São Paulo, 04231-030
About this study
Official 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
- 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Inhaled insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin
Secondary outcomes (4)
Change from baseline in fasting plasma glucose. Other secondary efficacy
endpoints include, body weight, patient reported outcomes, incidence and severity
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
insufficient clinical response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150410
- Sponsor's protocol ID
- A2171017
- Status last verified
- Oct 2008
- First submitted
- 6 Sep 2005
- Last updated
- 31 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00150410
- Acronym / sponsor ID
- A2171017
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jan 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Currently treated and on a stable doses of drugs for the preceding two (2) months
Key exclusion criteria (2 listed)
- Type 1 Diabetes
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled insulin | Drug | – |
Primary outcome
Glycosylated hemoglobin
4 secondary outcomes
Change from baseline in fasting plasma glucose. Other secondary efficacy
endpoints include, body weight, patient reported outcomes, incidence and severity
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
insufficient clinical response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
119 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled insulin in people with Diabetes Mellitus, run by Pfizer at 119 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Canada, Mexico, Australia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.