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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Exubera Exubera Exubera

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No