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)
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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
Self-Monitoring Blood Glucose Levels: Change From Baseline
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Time frame: One year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Pfizer Investigational Site
Takatsuki-shi, Oosaka, Japan
Pfizer Investigational Site
Osaka, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Toyama, Toyama, Japan
Pfizer Investigational Site
Tokyo, Japan
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Baseline, Week 6, Week 12, End of treatment