Diabetes Mellitus, Type 2Phase 3NCT00424411
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
A Phase 3 study testing Inhaled human insulin (EXUBERA™) in people with Diabetes Mellitus, Type 2, run by Pfizer at 45 sites in 2 countries.
Trial summary
To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Inhaled human insulin (EXUBERA™)
- How many people
- 300 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Sep 1999to Dec 2000
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes
- Stable insulin regimen of at least 2 injections per day
Who cannot join
- Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
- Subjects on insulin pump during 2 months prior to screening.
- Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States34 sites
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Burlingame, California
Pfizer Investigational Site
Burlington, Vermont
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Clearwater, Florida
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Columbia, Missouri
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Durham, North Carolina
Pfizer Investigational Site
Greenville, North Carolina
Pfizer Investigational Site
Irvine, California
Pfizer Investigational Site
Irving, Texas
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Louisville, Kentucky
Pfizer Investigational Site
Miami, Florida
Pfizer Investigational Site
New Haven, Connecticut
Pfizer Investigational Site
New Hyde Park, New York
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Newport Beach, California
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Orange, California
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Renton, Washington
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
San Francisco, California
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Tustin, California
Pfizer Investigational Site
Washington D.C., District of Columbia
Pfizer Investigational Site
Winston-Salem, North Carolina
Canada11 sites
Pfizer Investigational Site
Calgary, Alberta
Pfizer Investigational Site
Chomedy, Quebec
Pfizer Investigational Site
Edmonton, Alberta
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Mississauga, Ontario
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Ottawa, Ontario
Pfizer Investigational Site
Red Deer, Alberta
Pfizer Investigational Site
St. John's, Newfoundland and Labrador
Pfizer Investigational Site
Toronto, Ontario
Pfizer Investigational Site
Winnipeg, Manitoba
About this study
Official title: Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
To determine, in subjects with Type 2 Diabetes Mellitus:
- Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
- The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Inhaled human insulin (EXUBERA™)
- 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.
Inhaled human insulin (EXUBERA™)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is 24 week change in baseline in HbA1c.
Secondary outcomes (10)
The secondary endpoints include the following efficacy assessments:
Incidence of hypoglycemia
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Change from baseline in fasting lipid profile
Change from baseline in fasting plasma glucose level
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Change from baseline in body weight
Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
Patient satisfaction and preference.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startSep 1999
- Study completionDec 2000
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424411
- Sponsor's protocol ID
- 217-108
- Status last verified
- Feb 2007
- First submitted
- 17 Jan 2007
- Last updated
- 13 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
- ClinicalTrials.gov ID
- NCT00424411
- Acronym / sponsor ID
- 217-108
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Study completion
- Dec 2000
- First posted
- 19 Jan 2007 (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.
To determine, in subjects with Type 2 Diabetes Mellitus:
- Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
- The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes
- Stable insulin regimen of at least 2 injections per day
Key exclusion criteria (3 listed)
- Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
- Subjects on insulin pump during 2 months prior to screening.
- Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
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 human insulin (EXUBERA™) | Drug | – |
Primary outcome
Primary outcome is 24 week change in baseline in HbA1c.
10 secondary outcomes
The secondary endpoints include the following efficacy assessments:
Incidence of hypoglycemia
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Change from baseline in fasting lipid profile
Change from baseline in fasting plasma glucose level
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Change from baseline in body weight
Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
Patient satisfaction and preference.
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 13 Feb 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
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled human insulin (EXUBERA™) in people with Diabetes Mellitus, Type 2, run by Pfizer at 45 sites in 2 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 3 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 13 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. 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?
Primary outcome is 24 week change in baseline in HbA1c.. 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 13 Feb 2007.