- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527397
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
October 5, 2009 updated by: Pfizer
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)
Study Overview
Status
Terminated
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kyoto, Japan
- Pfizer Investigational Site
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Osaka, Japan
- Pfizer Investigational Site
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Tokyo, Japan
- Pfizer Investigational Site
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Aichi
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Nagoya-shi, Aichi, Japan
- Pfizer Investigational Site
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Kanagawa
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Yokohama-shi, Kanagawa, Japan
- Pfizer Investigational Site
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Nara
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Tenri-shi, Nara, Japan
- Pfizer Investigational Site
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Oosaka
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Takatsuki-shi, Oosaka, Japan
- Pfizer Investigational Site
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Tokyo
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Bunkyo-ku, Tokyo, Japan
- Pfizer Investigational Site
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Meguro-ku, Tokyo, Japan
- Pfizer Investigational Site
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Toyama
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Toyama-shi, Toyama, Japan
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
|
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.
Other Names:
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.
Other Names:
|
Experimental: C
Type 2 DM who has already treated by Insulin
|
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.
Other Names:
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.
Other Names:
|
Experimental: A
Type 1 DM
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Monitoring Blood Glucose Levels: Change From Baseline
Time Frame: One year
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Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Inhaled Insulin Dose
Time Frame: Up to 26 weeks
|
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.
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Up to 26 weeks
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The Values of Hemoglobin A1c:Change From Baseline
Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment
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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.
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Baseline, Week 6, Week 12, Week 26, End of treatment
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The Value of Fasting Plasma Glucose:Change From Baseline
Time Frame: Baseline, Week 6, Week 12, Week 26
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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.
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Baseline, Week 6, Week 12, Week 26
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The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
Time Frame: 0 month to 12 months
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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
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0 month to 12 months
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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
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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.
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Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
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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
|
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.
|
Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment
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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
|
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.
|
Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment
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Insulin Antibody Levels : Change From Baseline
Time Frame: Baseline, Week 6, Week 12, End of treatment
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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.
|
Baseline, Week 6, Week 12, End of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 7, 2007
First Submitted That Met QC Criteria
September 7, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
October 15, 2009
Last Update Submitted That Met QC Criteria
October 5, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2171105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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