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Trial record 1 of 1 for:    NCT00527397
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Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527397
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 10, 2007
Results First Posted : October 5, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 7, 2007
First Posted Date  ICMJE September 10, 2007
Results First Submitted Date  ICMJE July 15, 2009
Results First Posted Date  ICMJE October 5, 2009
Last Update Posted Date October 15, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
Self-Monitoring Blood Glucose Levels: Change From Baseline [ Time Frame: One year ]
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
All cause adverse events for one year; the change in the pulmonary function test value (FEV1, FVC) for one year, insulin antibody level and the data for hypoglycemia and abnormal laboratory changes for one year
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • Daily Inhaled Insulin Dose [ Time Frame: Up to 26 weeks ]
    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 [ Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment ]
    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 [ Time Frame: Baseline, Week 6, Week 12, Week 26 ]
    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 [ Time Frame: 0 month to 12 months ]
    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 [ Time Frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 ]
    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 [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment ]
    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 [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment ]
    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 [ Time Frame: Baseline, Week 6, Week 12, End of treatment ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
  • HbA1c [ Time Frame: Weeks -4, -1, 6, 12, 26, 38, 52 ]
  • Fasting blood glucose levels [ Time Frame: Weeks -1,-1, 6, 12, 26, 38, 52 ]
  • The data for SMBG and Hypoglycemia [ Time Frame: For 1 year, Initial dose (day 1) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
Official Title  ICMJE An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: CP-464,005
    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.
    Other Name: Exubera
  • Drug: CP-464,005
    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.
    Other Name: Exubera
Study Arms  ICMJE
  • Experimental: B
    Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
    Intervention: Drug: CP-464,005
  • Experimental: C
    Type 2 DM who has already treated by Insulin
    Intervention: Drug: CP-464,005
  • Experimental: A
    Type 1 DM
    Intervention: Drug: CP-464,005
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 1, 2009)
24
Original Enrollment  ICMJE
 (submitted: September 7, 2007)
189
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00527397
Other Study ID Numbers  ICMJE A2171105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP