Diabetes Mellitus, Type 2Phase 3NCT00370565
Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
A Phase 3 study testing Inhaled Human Insulin in people with Diabetes Mellitus, Type 2, run by Pfizer at 52 sites in 2 countries.
Trial summary
To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents. 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
- How many people
- 345 participants
- Where
- 52 sitesin 2 countries
- Study dates
- Jun 1999to Sep 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 Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
- Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).
Who cannot join
- Asthma, COPD
- Smoking during the previous 6 months
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
United States37 sites
Pfizer Investigational Site
Austin, Texas, 78758
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75235-8858
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Greenville, North Carolina, 27858
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Irvine, California, 92618
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Los Angeles, California, 90059
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneapolis, Minnesota, 55416
Pfizer Investigational Site
New Britain, Connecticut, 06050
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Haven, Connecticut, 06519
Pfizer Investigational Site
New Orleans, Louisiana, 70121
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
New York, New York, 10025
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Portland, Oregon, 97201-3098
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Canada15 sites
Pfizer Investigational Site
Calgary, Alberta, T3B 0M3
Pfizer Investigational Site
Edmonton, Alberta, T5H 3V9
Pfizer Investigational Site
Edmonton, Alberta, T6G 2C8
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4E9
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
Pfizer Investigational Site
Toronto, Ontario, M5B 1WB
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.
To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Inhaled Human Insulin
- 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 InsulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.
Secondary outcomes (7)
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startJun 1999
- Study completionSep 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
- 345 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370565
- Sponsor's protocol ID
- 217-109
- Status last verified
- Feb 2007
- First submitted
- 29 Aug 2006
- 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 Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.
- ClinicalTrials.gov ID
- NCT00370565
- Acronym / sponsor ID
- 217-109
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi, Nektar Therapeutics
- Study start
- Jun 1999
- Study completion
- Sep 2000
- First posted
- 31 Aug 2006 (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 assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.
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 Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
- Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).
Key exclusion criteria (2 listed)
- Asthma, COPD
- Smoking during the previous 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 |
|---|---|---|
| Inhaled Human Insulin | Drug | – |
Primary outcome
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.
7 secondary outcomes
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
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
52 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 in people with Diabetes Mellitus, Type 2, run by Pfizer at 52 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 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 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 52 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?
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.. The study lists 2 primary outcomes in all. 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.