Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inhaled human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes for more than 1 year
- 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Primary outcome is 24 week change in baseline in HbA1c
Secondary Outcome Measures
The secondary endpoints include the following efficacy assessments:
Incidence of hypoglycemia
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Change from baseline in fasting lipid profile
Change from baseline in fasting plasma glucose level
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Change from baseline in body weight
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).
Patient satisfaction and preference.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00424437
Brief Title
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
Official Title
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine, in subjects with Type 1 Diabetes Mellitus:
Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled human insulin
Primary Outcome Measure Information:
Title
Primary outcome is 24 week change in baseline in HbA1c
Secondary Outcome Measure Information:
Title
The secondary endpoints include the following efficacy assessments:
Title
Incidence of hypoglycemia
Title
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Title
Change from baseline in fasting lipid profile
Title
Change from baseline in fasting plasma glucose level
Title
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Title
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Title
Change from baseline in body weight
Title
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).
Title
Patient satisfaction and preference.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes for more than 1 year
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Burlingame
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Pfizer Investigational Site
City
St John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=106&StudyName=Six+Month+Clinical+Trial+Assessing+Efficacy+And+Safety+Of+Inhaled+Insulin+In+Type+1+Diabetes+Mellitus%2E
Description
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Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
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