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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527397
• Other study ID #: A2171105
• Status: Terminated
• Phase: Phase 3
• First received: September 7, 2007
• Last updated: October 5, 2009
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Meguro-ku	Tokyo
Japan	Pfizer Investigational Site	Nagoya-shi	Aichi
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Takatsuki-shi	Oosaka
Japan	Pfizer Investigational Site	Tenri-shi	Nara
Japan	Pfizer Investigational Site	Tokyo
Japan	Pfizer Investigational Site	Toyama-shi	Toyama
Japan	Pfizer Investigational Site	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Monitoring Blood Glucose Levels: Change From Baseline		One year	No
Secondary	Daily Inhaled Insulin Dose		Up to 26 weeks	No
Secondary	The Values of Hemoglobin A1c:Change From Baseline		Baseline, Week 6, Week 12, Week 26, End of treatment	No
Secondary	The Value of Fasting Plasma Glucose:Change From Baseline		Baseline, Week 6, Week 12, Week 26	No
Secondary	The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin		0 month to 12 months	No
Secondary	The Values of Forced Expiratory Volume at 1 Second:Change From Baseline		Beseline, Week 1, Week 2, Week 6, Week 12, Week 26	Yes
Secondary	The Values of Forced Vital Capacity:Change From Baseline		Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment	Yes
Secondary	The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline		Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment	Yes
Secondary	Insulin Antibody Levels : Change From Baseline		Baseline, Week 6, Week 12, End of treatment	Yes

External Links

•   To obtain contact information for a study center near you, click here.