Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

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

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
Brief Summary

To determine, in subjects with Type 1 Diabetes Mellitus:

1. 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.

2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.

Overall Status Completed
Start Date September 1999
Completion Date September 2000
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary outcome is 24 week change in baseline in HbA1c
Secondary Outcome
Measure Time Frame
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.
Enrollment 320
Condition
Intervention

Intervention Type: Drug

Intervention Name: Inhaled human insulin

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.

Gender: All

Minimum Age: 12 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Pfizer Investigational Site | Burlingame, California, United States
Pfizer Investigational Site | Irvine, California, United States
Pfizer Investigational Site | Newport Beach, California, United States
Pfizer Investigational Site | San Diego, California, United States
Pfizer Investigational Site | San Francisco, California, United States
Pfizer Investigational Site | Tustin, California, United States
Pfizer Investigational Site | Hartford, Connecticut, United States
Pfizer Investigational Site | Washington, District of Columbia, United States
Pfizer Investigational Site | Atlanta, Georgia, United States
Pfizer Investigational Site | Stockbridge, Georgia, United States
Pfizer Investigational Site | Chicago, Illinois, United States
Pfizer Investigational Site | Lexington, Kentucky, United States
Pfizer Investigational Site | Columbia, Missouri, United States
Pfizer Investigational Site | St Louis, Missouri, United States
Pfizer Investigational Site | St. Louis, Missouri, United States
Pfizer Investigational Site | Omaha, Nebraska, United States
Pfizer Investigational Site | Albuquerque, New Mexico, United States
Pfizer Investigational Site | Buffalo, New York, United States
Pfizer Investigational Site | Manhasset, New York, United States
Pfizer Investigational Site | New Hyde Park, New York, United States
Pfizer Investigational Site | New York, New York, United States
Pfizer Investigational Site | Greenville, North Carolina, United States
Pfizer Investigational Site | Cleveland, Ohio, United States
Pfizer Investigational Site | Portland, Oregon, United States
Pfizer Investigational Site | Austin, Texas, United States
Pfizer Investigational Site | Dallas, Texas, United States
Pfizer Investigational Site | Irving, Texas, United States
Pfizer Investigational Site | San Antonio, Texas, United States
Pfizer Investigational Site | Charlottesville, Virginia, United States
Pfizer Investigational Site | Renton, Washington, United States
Pfizer Investigational Site | Calgary, Alberta, Canada
Pfizer Investigational Site | Winnipeg, Manitoba, Canada
Pfizer Investigational Site | St John's, Newfoundland and Labrador, Canada
Pfizer Investigational Site | Halifax, Nova Scotia, Canada
Pfizer Investigational Site | London, Ontario, Canada
Pfizer Investigational Site | Toronto, Ontario, Canada
Pfizer Investigational Site | Laval, Quebec, Canada
Location Countries

Canada

United States

Verification Date

February 2007

Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov