Overview

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

Status:
Terminated
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Insulin
Insulin, Globin Zinc
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.