Diabetes MellitusPhase 2NCT00143247

Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

A Phase 2 study testing Exubera® (inhaled insulin) in people with Diabetes Mellitus, run by Pfizer at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Exubera® (inhaled insulin)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 12 sitesUnited States
Study dates: Mar 2003to Jan 2008
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Who cannot join

Smoking
Pregnancy

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87131-5666
Pfizer Investigational Site
Austin, Texas, 78752
Pfizer Investigational Site
Austin, Texas, 78758
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75243
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New Haven, Connecticut, 06504
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Read the detailed description

The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.

Conditions: Diabetes Mellitus
Being tested: Exubera® (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.

Exubera® (inhaled insulin)Drug
Also called Exubera®
Treatment of type 1 and type 2 diabetes with short-acting insulin

Study groups in NCT00143247
Study group	Role	What they receive
Exubera® (inhaled insulin)	Experimental	Open label, no comparator Receives: Drug: Exubera® (inhaled insulin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Measured: Baseline to 126 months
Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Measured: baseline to 126 months

Secondary outcomes (9)

Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Measured: Baseline to 126 months
Hypoglycemic Event Rates by Interval of Exubera Treatment
Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled \& uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.
Measured: 0 to 132 months
Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled \& uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.
Measured: 0-132 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
Observed values by duration of treatment.
Measured: 36 months to 126 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
observed values by duration of treatment.
Measured: 36 to 126 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
Observed values by duration of treatment.
Measured: 6 to 120 months
Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment
Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.
Measured: 3 to >=108 months
Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.
Measured: 3 to >=108 months
Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.
Measured: 6 to >=108 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Jan 2008

First posted2 Sep 2005 (estimated)
Study startMar 2003
Primary completionJan 2008
Study completionJan 2008

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 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00143247
Sponsor's protocol ID: A2171036
Status last verified: Jul 2009
First submitted: 31 Aug 2005
Last updated: 15 Apr 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104
ClinicalTrials.gov ID: NCT00143247
Acronym / sponsor ID: A2171036
Conditions: Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 173 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2003
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 2 Sep 2005 (estimated)
Results: Posted 9 Nov 2009

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 long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Exubera® (inhaled insulin)	Experimental	Drug: Exubera® (inhaled insulin)Open label, no comparator

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Key exclusion criteria (2 listed)

Smoking
Pregnancy

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
Exubera® (inhaled insulin)Also: Exubera®Treatment of type 1 and type 2 diabetes with short-acting insulin	Drug	Exubera® (inhaled insulin)

Primary outcome

Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
Time frame: Baseline to 126 months
Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
Time frame: baseline to 126 months
Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.

9 secondary outcomes

Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
Time frame: Baseline to 126 months
Hypoglycemic Event Rates by Interval of Exubera Treatment
Time frame: 0 to 132 months
Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
Time frame: 0-132 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
Time frame: 36 months to 126 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
Time frame: 36 to 126 months
Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
Time frame: 6 to 120 months
Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment
Time frame: 3 to >=108 months
Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
Time frame: 3 to >=108 months
Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
Time frame: 6 to >=108 months

Results and safety

Results posted to the registry on 9 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhaled Insulin	173	17

Primary outcome: Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment

Time frame: Baseline to 126 months. Mean (Standard Deviation). Unit: liters

Measure	Inhaled Insulin n = 156
3 months (n=154)	-0.077 (0.204)
6 months (n=149)	-0.101 (0.204)
12 months (n=138)	-0.137 (0.220)
18 months (n=123)	-0.141 (0.218)
24 months (n=116)	-0.184 (0.232)
30 months (n=108)	-0.210 (0.237)
36 months (n=101)	-0.253 (0.244)
42 months (n=92)	-0.288 (0.217)

Population analysed: 173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.

Primary outcome: Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment

Time frame: baseline to 126 months. Mean (Standard Deviation). Unit: mL/min/mm Hg

Measure	Inhaled Insulin n = 152
6 months (n=149)	-1.200 (4.358)
12 months (n=130)	-1.262 (4.446)
18 months (n=115)	-1.883 (4.690)
24 months (n=113)	-2.012 (4.821)
30 months (n=100)	-1.601 (5.816)
36 months (n=95)	-2.122 (5.030)
42 months (n=86)	-2.550 (5.307)
48 months (n=82)	-1.827 (3.623)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaled Insulin	63 of ?	172 of ?	Not reported

Limitations and caveats (from the sponsor): Study terminated early due to business and operational issues. All subjects who were treated with inhaled insulin in parent protocols(217-102,-103,or-104) or in extension protocols (217-102E,-103E,-104E,or A2171036)are included in safety evaluation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
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.

Related trials for Diabetes Mellitus

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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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exubera® (inhaled insulin) in people with Diabetes Mellitus, run by Pfizer at 12 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 1 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 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Nov 2009). 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?

Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment (time frame: Baseline to 126 months). 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?

On the ClinicalTrials.gov record for NCT00143247.

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 15 Apr 2010.