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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Drug: CP-464,005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527397

A2171105

Details and patient eligibility

About

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)

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

B

Experimental group

Description:

Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin

Treatment:

Drug: CP-464,005

Drug: CP-464,005

Drug: CP-464,005

C

Experimental group

Description:

Type 2 DM who has already treated by Insulin

Treatment:

Drug: CP-464,005

Drug: CP-464,005

Drug: CP-464,005

A

Experimental group

Description:

Type 1 DM

Treatment:

Drug: CP-464,005

Drug: CP-464,005

Drug: CP-464,005