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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00527397
First received: September 7, 2007
Last updated: October 5, 2009
Last verified: July 2009
History of Changes

September 7, 2007
October 5, 2009
August 2007
July 2008   (final data collection date for primary outcome measure)
Self-Monitoring Blood Glucose Levels: Change From Baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00527397 on ClinicalTrials.gov Archive Site
  • Daily Inhaled Insulin Dose [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
  • The Values of Hemoglobin A1c:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment ] [ Designated as safety issue: No ]
  • The Value of Fasting Plasma Glucose:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26 ] [ Designated as safety issue: No ]
  • The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin [ Time Frame: 0 month to 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Insulin Antibody Levels : Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, End of treatment ] [ Designated as safety issue: Yes ]
  • 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) ]
Not Provided
Not Provided
 
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
16 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00527397
A2171105
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

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