Diabetes Mellitus, Type 1Phase 3NCT00479258
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
A Phase 3 study testing Inhaled insulin (Exubera) and Subcutaneous Insulin (subject's prescribed) in people with Diabetes Mellitus, Type 1, run by Pfizer at 1 site in United States.
Trial summary
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Inhaled insulin (Exubera) and Subcutaneous Insulin (subject's prescribed)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with Type 1 diabetes mellitus for more than 6 months.
- Males and females ages 6 to 17 years.
- Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.
Who cannot join
- Subjects using an insulin pump
- Smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Buffalo, New York, 14222
About this study
Official title: Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial.
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
Read the detailed description
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171083 was terminated and no further recruitment took place.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Inhaled insulin (Exubera), Subcutaneous Insulin (subject's prescribed)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled insulin (Exubera)Drug
Inhaled insulin with dose adjusted according to premeal blood glucose
Subcutaneous Insulin (subject's prescribed)Drug
Subcutaneous insulin with dose adjusted according to premeal blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Inhaled insulin (Exubera) | Experimental | Not described Receives: Drug: Inhaled insulin (Exubera) |
| Subcutaneous Insulin (subject's prescribed) | Active comparator | Not described Receives: Drug: Subcutaneous Insulin (subject's prescribed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
No subjects were dosed therefore no data collected.
Measured: 12 months
Secondary outcomes (10)
Change From Baseline in Other PFT Parameters
Measured: 12 months
Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;
Measured: 12 months
Treatment Preferences.
Measured: 12 months
Change From Baseline in FVC
Measured: 12 months
Slope for Other PFT Parameters;
Measured: 12 months
Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
Measured: 12 months
Change From Baseline in Insulin Antibodies (microU/mL);
Measured: 12 months
Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;
Measured: 12 months
Hypoglycemic Event Rates;
Measured: 12 months
7 Point Home Glucose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479258
- Sponsor's protocol ID
- A2171083
- Status last verified
- Aug 2018
- First submitted
- 24 May 2007
- Last updated
- 1 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial.
- ClinicalTrials.gov ID
- NCT00479258
- Acronym / sponsor ID
- A2171083
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Posted 3 Nov 2008
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 safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
Detailed description
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171083 was terminated and no further recruitment took place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled insulin (Exubera) | Experimental | Drug: Inhaled insulin (Exubera) |
| Subcutaneous Insulin (subject's prescribed) | Active comparator | Drug: Subcutaneous Insulin (subject's prescribed) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects with Type 1 diabetes mellitus for more than 6 months.
- Males and females ages 6 to 17 years.
- Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.
Key exclusion criteria (2 listed)
- Subjects using an insulin pump
- 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 (Exubera)Inhaled insulin with dose adjusted according to premeal blood glucose | Drug | Inhaled insulin (Exubera) |
| Subcutaneous Insulin (subject's prescribed)Subcutaneous insulin with dose adjusted according to premeal blood glucose | Drug | Subcutaneous Insulin (subject's prescribed) |
Primary outcome
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
Time frame: 12 months
No subjects were dosed therefore no data collected.
10 secondary outcomes
Change From Baseline in Other PFT Parameters
Time frame: 12 months
Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;
Time frame: 12 months
Treatment Preferences.
Time frame: 12 months
Change From Baseline in FVC
Time frame: 12 months
Slope for Other PFT Parameters;
Time frame: 12 months
Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
Time frame: 12 months
Change From Baseline in Insulin Antibodies (microU/mL);
Time frame: 12 months
Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;
Time frame: 12 months
Hypoglycemic Event Rates;
Time frame: 12 months
7 Point Home Glucose
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled insulin (Exubera) and Subcutaneous Insulin (subject's prescribed) in people with Diabetes Mellitus, Type 1, run by Pfizer at 1 site 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: stopped early, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 3 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period (time frame: 12 months). 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 1 Oct 2018.