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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CP-464,005
CP-464,005
CP-464,005
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

B

C

A

Arm Description

Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin

Type 2 DM who has already treated by Insulin

Type 1 DM

Outcomes

Primary Outcome Measures

Self-Monitoring Blood Glucose Levels: Change From Baseline
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
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.
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.

Full Information

First Posted
September 7, 2007
Last Updated
October 5, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00527397
Brief Title
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
Official Title
An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
Arm Title
C
Arm Type
Experimental
Arm Description
Type 2 DM who has already treated by Insulin
Arm Title
A
Arm Type
Experimental
Arm Description
Type 1 DM
Intervention Type
Drug
Intervention Name(s)
CP-464,005
Other Intervention Name(s)
Exubera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CP-464,005
Other Intervention Name(s)
Exubera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CP-464,005
Other Intervention Name(s)
Exubera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-Monitoring Blood Glucose Levels: Change From Baseline
Description
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Daily Inhaled Insulin Dose
Description
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
Title
The Values of Hemoglobin A1c:Change From Baseline
Description
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
Title
The Value of Fasting Plasma Glucose:Change From Baseline
Description
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
Title
The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
Description
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
Title
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Description
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.
Time Frame
Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
Title
The Values of Forced Vital Capacity:Change From Baseline
Description
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
Title
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Description
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
Title
Insulin Antibody Levels : Change From Baseline
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya-shi
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tenri-shi
State/Province
Nara
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takatsuki-shi
State/Province
Oosaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toyama-shi
State/Province
Toyama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171105&StudyName=Long-Term%20Safety%20Study%20Of%20Inhaled%20Insulin%20%28CP-464%2C005%2C%20CP-464%2C005/Inhaler%29%20In%20Japanese%20Patients%20With%20Type1%20or%20Type2%20Diabetes
Description
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Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

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