Diabetes Mellitus, Type 2Phase 3NCT00527397
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
A Phase 3 study testing CP-464,005 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Pfizer at 10 sites in Japan.
Trial summary
Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers) Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- CP-464,005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 10 sitesJapan
- Study dates
- Aug 2007to Jul 2008
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.
Who cannot join
- Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well)
- Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 < 70% of predicted) ) at Week -4.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Kyoto, Kyoto
Pfizer Investigational Site
Meguro-ku, Tokyo
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Takatsuki-shi, Oosaka
Pfizer Investigational Site
Tenri-shi, Nara
Pfizer Investigational Site
Tokyo
Pfizer Investigational Site
Toyama, Toyama
Pfizer Investigational Site
Yokohama, Kanagawa
About this study
Official title: An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)
Read the detailed description
Pfizer announced in October 2007 that it would stop marketing CP-464,005. At that time recruitment for study, A2171105 was placed on hold. Nektar, the company from which Pfizer licensed CP-464,005, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171105 was terminated on April 10, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
- Being tested
- CP-464,005
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-464,005Drug
Also called Exubera
Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
CP-464,005Drug
Also called Exubera
Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
CP-464,005Drug
Also called Exubera
Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose:adjusted based on the results of self-monitoring of blood glucose before each meal.
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin Receives: Drug: CP-464,005 |
| C | Experimental | Type 2 DM who has already treated by Insulin Receives: Drug: CP-464,005 |
| A | Experimental | Type 1 DM Receives: Drug: CP-464,005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Monitoring Blood Glucose Levels: Change From Baseline
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Measured: One year
Secondary outcomes (8)
Daily Inhaled Insulin Dose
The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Up to 26 weeks
The Values of Hemoglobin A1c:Change From Baseline
Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Baseline, Week 6, Week 12, Week 26, End of treatment
The Value of Fasting Plasma Glucose:Change From Baseline
Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Baseline, Week 6, Week 12, Week 26
The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44
Measured: 0 month to 12 months
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
The Values of Forced Vital Capacity:Change From Baseline
pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment
Insulin Antibody Levels : Change From Baseline
Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Measured: Baseline, Week 6, Week 12, End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT00527397
- Sponsor's protocol ID
- A2171105
- Status last verified
- Jul 2009
- First submitted
- 7 Sep 2007
- Last updated
- 15 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00527397
- Acronym / sponsor ID
- A2171105
- Keywords
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 5 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)
Detailed description
Pfizer announced in October 2007 that it would stop marketing CP-464,005. At that time recruitment for study, A2171105 was placed on hold. Nektar, the company from which Pfizer licensed CP-464,005, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171105 was terminated on April 10, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: CP-464,005Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin |
| C | Experimental | Drug: CP-464,005Type 2 DM who has already treated by Insulin |
| A | Experimental | Drug: CP-464,005Type 1 DM |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.
Key exclusion criteria (2 listed)
- Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well)
- Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 < 70% of predicted) ) at Week -4.
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 |
|---|---|---|
| CP-464,005Also: ExuberaTaken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal. | Drug | C |
| CP-464,005Also: ExuberaTaken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal. | Drug | A |
| CP-464,005Also: ExuberaTaken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose:adjusted based on the results of self-monitoring of blood glucose before each meal. | Drug | B |
Primary outcome
Self-Monitoring Blood Glucose Levels: Change From Baseline
Time frame: One year
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
8 secondary outcomes
Daily Inhaled Insulin Dose
Time frame: Up to 26 weeks
The Values of Hemoglobin A1c:Change From Baseline
Time frame: Baseline, Week 6, Week 12, Week 26, End of treatment
The Value of Fasting Plasma Glucose:Change From Baseline
Time frame: Baseline, Week 6, Week 12, Week 26
The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
Time frame: 0 month to 12 months
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Time frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
The Values of Forced Vital Capacity:Change From Baseline
Time frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Time frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment
Insulin Antibody Levels : Change From Baseline
Time frame: Baseline, Week 6, Week 12, End of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- 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
10 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 CP-464,005 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Pfizer at 10 sites in Japan.
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 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. 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 5 Oct 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?
Self-Monitoring Blood Glucose Levels: Change From Baseline (time frame: One year). 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 15 Oct 2009.