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
  Purpose

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)


Condition Intervention Phase
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Drug: CP-464,005
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Self-Monitoring Blood Glucose Levels: Change From Baseline [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
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: C
Type 2 DM who has already treated by Insulin
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: A
Type 1 DM
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527397

Locations
Japan
Pfizer Investigational Site
Nagoya-shi, Aichi, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa, Japan
Pfizer Investigational Site
Tenri-shi, Nara, Japan
Pfizer Investigational Site
Takatsuki-shi, Oosaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Toyama-shi, Toyama, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00527397     History of Changes
Other Study ID Numbers: A2171105
Study First Received: September 7, 2007
Results First Received: July 15, 2009
Last Updated: October 5, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014