Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: CP-464,005
* Drug: CP-464,005
* Drug: CP-464,005


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin | Drug: CP-464,005<br>* 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.<br>* Other names: Exubera;|
| Experimental: C<br>Type 2 DM who has already treated by Insulin | Drug: CP-464,005<br>* 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.<br>* Other names: Exubera;|
| Experimental: A<br>Type 1 DM | Drug: CP-464,005<br>* 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.<br>* Other names: Exubera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus