Clinical trial NCT00527397: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self-Monitoring Blood Glucose Levels: Change From Baseline
timeFrame: One year
Secondary outcomes:
measure: Daily Inhaled Insulin Dose
timeFrame: Up to 26 weeks
measure: The Values of Hemoglobin A1c:Change From Baseline
timeFrame: Baseline, Week 6, Week 12, Week 26, End of treatment
measure: The Value of Fasting Plasma Glucose:Change From Baseline
timeFrame: Baseline, Week 6, Week 12, Week 26
measure: The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
timeFrame: 0 month to 12 months
measure: The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
timeFrame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
measure: The Values of Forced Vital Capacity:Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment
measure: The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment
measure: Insulin Antibody Levels : Change From Baseline
timeFrame: Baseline, Week 6, Week 12, End of treatment
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Tenri-shi
country: Japan
facility: Pfizer Investigational Site
state: Nara
city: Takatsuki-shi
country: Japan
facility: Pfizer Investigational Site
state: Oosaka
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Toyama
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: