NCT00527397|TerminatedPhase 3Results
Study Stopped
See termination reason in detailed description.
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See termination reason in detailed description.
An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
Sponsor study identifier
interventional
24
1 country
10
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 7, 2007
Actual (reported)September 10, 2007
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)October 5, 2009
Actual (reported)Self-Monitoring Blood Glucose Levels: Change From Baseline
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
One year
Daily Inhaled Insulin Dose
Up to 26 weeks
The Values of Hemoglobin A1c:Change From Baseline
Baseline, Week 6, Week 12, Week 26, End of treatment
The Value of Fasting Plasma Glucose:Change From Baseline
Baseline, Week 6, Week 12, Week 26
The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
0 month to 12 months
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
Type 2 DM who has already treated by Insulin
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.
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.
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Kyoto, Kyoto, Japan
Pfizer Investigational Site
Tenri-shi, Nara, Japan
Pfizer Investigational Site
Takatsuki-shi, Oosaka, Japan
Pfizer Investigational Site
Osaka, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.
Pfizer CT.gov Call Center
Pfizer
24 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2007
First Posted
September 10, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Toyama, Toyama, Japan
Pfizer Investigational Site
Tokyo, Japan
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
October 15, 2009
Results First Posted
October 5, 2009
Record last verified: 2009-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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