Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370565
• Other study ID #: 217-109
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2006
• Last updated: February 9, 2007
• Start date: June 1999
• Est. completion date: September 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

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 2

Intervention

Drug:
• Inhaled Human Insulin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	St John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Greenville	North Carolina
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Irvine	California
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Winston-salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Nektar Therapeutics, Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
Primary	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	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)
Secondary	Meal glucose response measured at Week -1 and at Week 12;
Secondary	These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
Secondary	not the subject’s home glucose monitoring results.
Secondary	Comparison of 24-hour home glucose profiles.
Secondary	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.
Secondary	A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.

External Links

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