| Trial ID: | L6907 |
| Source ID: | NCT00527397
|
| Associated Drug: |
Cp-464,005
|
| Title: |
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00527397/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: CP-464,005|DRUG: CP-464,005|DRUG: CP-464,005
|
| Outcome Measures: |
Primary: Self-Monitoring Blood Glucose Levels: Change From Baseline, Self-monitoring blood glucose levels obtained at each observation point minus that at baseline., One year | Secondary: 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., 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., 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., 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, 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., 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., 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., 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., Baseline, Week 6, Week 12, End of treatment
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-08
|
| Completion Date: |
2008-07
|
| Results First Posted: |
2009-10-05
|
| Last Update Posted: |
2009-10-15
|
| Locations: |
Pfizer Investigational Site, Nagoya-shi, Aichi, Japan|Pfizer Investigational Site, Yokohama-shi, Kanagawa, Japan|Pfizer Investigational Site, Tenri-shi, Nara, Japan|Pfizer Investigational Site, Takatsuki-shi, Oosaka, Japan|Pfizer Investigational Site, Bunkyo-ku, Tokyo, Japan|Pfizer Investigational Site, Meguro-ku, Tokyo, Japan|Pfizer Investigational Site, Toyama-shi, Toyama, Japan|Pfizer Investigational Site, Kyoto, Japan|Pfizer Investigational Site, Osaka, Japan|Pfizer Investigational Site, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00527397
|
