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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

NCT00418522

CompletedPhase 4

Sponsor: Pfizer

Conditions: Diabetes Mellitus, Type 2

Interventions: Insulin glargine, Inhaled Insulin (Exubera)

Countries: United States, Puerto Rico

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

Eligibility overview

Sex: ALL

Age: 30 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

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.

Locations (73)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Concord, California, United States
Encino, California, United States
Fresno, California, United States
Fullerton, California, United States
Long Beach, California, United States
Mission Viejo, California, United States
Pasadena, California, United States
San Diego, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
Spring Valley, California, United States
Stockton, California, United States
Walnut Creek, California, United States
West Hills, California, United States
Golden, Colorado, United States
Waterbury, Connecticut, United States
Newark, Delaware, United States
Chiefland, Florida, United States
Clearwater, Florida, United States
Hollywood, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Saint Cloud, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Lawrenceville, Georgia, United States
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