Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

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 a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.

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

Overall Status Completed
Start Date May 1999
Completion Date October 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 | Duarte, California, United States
Pfizer Investigational Site | Long Beach, California, United States
Pfizer Investigational Site | Los Angeles, California, United States
Pfizer Investigational Site | Stanford, California, United States
Pfizer Investigational Site | Denver, Colorado, United States
Pfizer Investigational Site | New Haven, Connecticut, United States
Pfizer Investigational Site | Gainesville, Florida, United States
Pfizer Investigational Site | Hollywood, Florida, United States
Pfizer Investigational Site | Miami, Florida, United States
Pfizer Investigational Site | Tallahassee, Florida, United States
Pfizer Investigational Site | Peoria, Illinois, United States
Pfizer Investigational Site | Skokie, Illinois, United States
Pfizer Investigational Site | Lutherville, Maryland, United States
Pfizer Investigational Site | Waltham, Massachusetts, United States
Pfizer Investigational Site | Minneapolis, Minnesota, United States
Pfizer Investigational Site | Columbia, Missouri, United States
Pfizer Investigational Site | Bronx, New York, United States
Pfizer Investigational Site | New Hyde Park, New York, United States
Pfizer Investigational Site | Rochester, New York, United States
Pfizer Investigational Site | Syracuse, New York, United States
Pfizer Investigational Site | Durham, North Carolina, United States
Pfizer Investigational Site | Winston-salem, North Carolina, United States
Pfizer Investigational Site | Portland, Oregon, United States
Pfizer Investigational Site | Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site | Dallas, Texas, United States
Pfizer Investigational Site | Houston, Texas, United States
Pfizer Investigational Site | Burlington, Vermont, United States
Pfizer Investigational Site | Charlottesville, Virginia, United States
Pfizer Investigational Site | Charlottsville, Virginia, United States
Pfizer Investigational Site | Seattle, Washington, United States
Pfizer Investigational Site | Edmonton, Alberta, Canada
Pfizer Investigational Site | Hamilton, Ontario, Canada
Pfizer Investigational Site | Mississauga, Ontario, Canada
Pfizer Investigational Site | Toronto, Ontario, Canada
Pfizer Investigational Site | Montreal, 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