Diabetes Mellitus, Type 2Phase 3NCT00139763
US Inhaled Insulin Therapeutic Choice Questionnaire Study
A Phase 3 study testing Educational Materials in people with Diabetes Mellitus, Type 2, run by Pfizer at 42 sites in United States.
Trial summary
This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Educational Materials
- Type of treatment
- Surgery or procedure
- How many people
- 740 participants
- Where
- 42 sitesUnited States
- Study dates
- Jul 2005to Mar 2006
- 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
- Male and female, age > = 18 years and <= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry
- Currently treated with either:
- 2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine
Who cannot join
- Type 1 diabetes
- Smoking within the past 6 months
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Pfizer Investigational Site
Arlington, Texas, 76014-2010
Pfizer Investigational Site
Bennington, Vermont, 05201-5018
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Colorado Springs, Colorado, 80904
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Detroit, Michigan, 48235
Pfizer Investigational Site
Elkton, Maryland, 21921
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Hayden, Idaho, 83835
Pfizer Investigational Site
Jacksonville, Florida, 32205
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Madisonville, Texas, 77864
Pfizer Investigational Site
Margate City, New Jersey, 08402-2218
Pfizer Investigational Site
Mesa, Arizona, 85201
Pfizer Investigational Site
Milwaukee, Wisconsin, 53218
Pfizer Investigational Site
Minneapolis, Minnesota, 55416
Pfizer Investigational Site
Morehead City, North Carolina, 28557
Pfizer Investigational Site
Nampa, Idaho, 83714
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orangeburg, South Carolina, 29118
Pfizer Investigational Site
Phoenix, Arizona, 85006-2850
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Portland, Oregon, 97219
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Santa Fe, New Mexico, 87505
Pfizer Investigational Site
Simpsonville, South Carolina, 29681
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Statesville, North Carolina, 28625
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Virginia Beach, Virginia, 23462
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010-2934
Pfizer Investigational Site
Wilmington, Delaware, 19805
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A US Randomized Questionnaire-Based Trial Assessing The Impact Of The Availability Of Inhaled Insulin On Therapeutic Choice In Patients With Suboptimally Controlled Type 2 Diabetes
This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.
This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Educational Materials
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational MaterialsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available
Secondary outcomes (1)
Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJul 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139763
- Sponsor's protocol ID
- A2171066
- Status last verified
- Mar 2007
- First submitted
- 29 Aug 2005
- Last updated
- 19 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A US Randomized Questionnaire-Based Trial Assessing The Impact Of The Availability Of Inhaled Insulin On Therapeutic Choice In Patients With Suboptimally Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00139763
- Acronym / sponsor ID
- A2171066
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jul 2005
- Study completion
- Mar 2006
- First posted
- 31 Aug 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.
This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.
This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.
Study design
- Primary purpose
- Early clinical test
- 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 (3 listed)
- Male and female, age > = 18 years and <= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry
- Currently treated with either:
- 2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Smoking within the past 6 months
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 |
|---|---|---|
| Educational Materials | Procedure or surgery | – |
Primary outcome
Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available
1 secondary outcome
Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice.
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 19 Mar 2007.
- 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
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational Materials in people with Diabetes Mellitus, Type 2, run by Pfizer at 42 sites in United States.
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 3 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 19 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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?
Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available. 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 19 Mar 2007.