Status:
COMPLETED
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Age \> 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made \> 6 months prior to study entry
- Screening HbA1c \> 7.0%
- Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione
Exclusion
- Smoking within last 6 months PFTs outside of range
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
- Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT \>1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00418522
Start Date
March 1 2007
End Date
August 1 2008
Last Update
September 28 2018
Active Locations (73)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
2
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
3
Pfizer Investigational Site
Concord, California, United States, 94520
4
Pfizer Investigational Site
Encino, California, United States, 91436