Clinical trial NCT00424411: Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
Official title: Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine, in subjects with Type 2 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

* Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
* Subjects on insulin pump during 2 months prior to screening.
* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.

Primary outcomes:
measure: Primary outcome is 24 week change in baseline in HbA1c.
Secondary outcomes:
measure: The secondary endpoints include the following efficacy assessments:
measure: Incidence of hypoglycemia
measure: Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
measure: Change from baseline in fasting lipid profile
measure: Change from baseline in fasting plasma glucose level
measure: Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
measure: Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
measure: Change from baseline in body weight
measure: Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
measure: Patient satisfaction and preference.
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Pfizer Investigational Site
state: California
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: St John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chomedy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: