Clinical trial NCT00370565: Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Official title: Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
name: Nektar Therapeutics
First posted: 2006-08-31
Enrollment: 345
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 assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
* Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

* Asthma, COPD
* Smoking during the previous 6 months

Primary outcomes:
measure: The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
measure: HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.
Secondary outcomes:
measure: Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
measure: Meal glucose response measured at Week -1 and at Week 12;
measure: These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
measure: not the subject's home glucose monitoring results.
measure: Comparison of 24-hour home glucose profiles.
measure: Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
measure: A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
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: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
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: Hollywood
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: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
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 York
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: 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: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
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: 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: Edmonton
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: 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: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: