Not provided
Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Experimental | Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin |
|
| C | Experimental | Type 2 DM who has already treated by Insulin |
|
| A | Experimental | Type 1 DM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-464,005 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Monitoring Blood Glucose Levels: Change From Baseline | Self-monitoring blood glucose levels obtained at each observation point minus that at baseline. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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 before it had recruited targeted number of subjects.
10 centers in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects With Type 1 or Type 2 Diabetes Mellitus | All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CP-464,005 | Drug | 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-464,005 | Drug | 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. |
|
|
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 |
| 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 |
| Pfizer Investigational Site | Meguro-ku | Tokyo | Japan |
| Pfizer Investigational Site | Toyama | Toyama | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects With Type 1 or Type 2 Diabetes Mellitus | All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively. | Posted | Mean | Standard Deviation | milligram | Up to 26 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively. | Posted | Mean | Standard Deviation | percent | Baseline, Week 6, Week 12, Week 26, End of treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively. | Posted | Mean | Standard Deviation | milligram/millilitre | Baseline, Week 6, Week 12, Week 26 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively. | Posted | Number | events / subject-month | 0 month to 12 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug. | Posted | Mean | Standard Deviation | liter | Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug. | Posted | Mean | Standard Deviation | liter | Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug. | Posted | Mean | Standard Deviation | liter/liter | Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively. | Posted | Mean | Standard Deviation | microunit/milliliter | Baseline, Week 6, Week 12, End of treatment |
|
| |||||||||||||||||||||||||||||||||
| Primary | Self-Monitoring Blood Glucose Levels: Change From Baseline | Self-monitoring blood glucose levels obtained at each observation point minus that at baseline. | This endopoint was not analyzed because of small numbers of subjects due to early termination | Posted | Mean | Standard Deviation | milligram/millilitre | One year |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects With Type 1 or Type 2 Diabetes Mellitus | all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. | 3 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Device malfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
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 has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C473734 | Exubera |
Not provided
Not provided
Not provided
|
| Day 3 (n=6, 12, 6) |
|
| Day 4 (n=6, 12, 6) |
|
| Day 5 (n=6, 12, 6) |
|
| Week 1 (n=6, 12, 6) |
|
| Week 2 (n=6, 11, 6) |
|
| Week 4 (n=5, 11, 6) |
|
| Week 6 (n=5, 9, 6) |
|
| Week 8 (n=5, 8, 6) |
|
| Week 12 (n=4, 7, 5) |
|
| Week 16 (n=3, 6, 3) |
|
| Week 20 (n=3, 5, 3) |
|
| Week 26 (n=3, 5, 3) |
|
| End of treatment (n=6, 12, 6) |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
| Participants |
|
|