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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424333
• Other study ID #: 217-107
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2007
• Last updated: February 9, 2007
• Start date: May 1999
• Est. completion date: October 2000

Study information

• Verified date: February 2007
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Inhaled human insulin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Mississauga	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Bronx	New York
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	Columbia	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Duarte	California
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Lutherville	Maryland
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Skokie	Illinois
United States	Pfizer Investigational Site	Stanford	California
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Waltham	Massachusetts
United States	Pfizer Investigational Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome is 24 week change in baseline in HbA1c.
Secondary	The secondary endpoints include the following efficacy assessments:
Secondary	Incidence of hypoglycemia
Secondary	Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Secondary	Change from baseline in fasting lipid profile
Secondary	Change from baseline in fasting plasma glucose level
Secondary	Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
Secondary	Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
Secondary	Change from baseline in body weight
Secondary	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).
Secondary	Patient satisfaction and preference.

External Links

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