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NCT00246623 Clinical Trial

US Inhaled Insulin Dose Titration Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00246623
Other study ID # A2171067
Secondary ID
Status Completed
Phase Phase 3
First received October 28, 2005
Last updated February 6, 2008
Start date November 2005
Est. completion date March 2007

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

Clinical Trial Summary

This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Male and female, age >= 18 years and <= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%

- Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)

Exclusion Criteria:

- Type 1 diabetes

- Smoking within the past 6 months or significant pulmonary diseases

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Exubera (inhaled insulin)

Procedure:
• 8-point glucose diary (to assess pre- and post prandial glucoses)

• Meal Tolerance Test

• 24-hour continuous glucose monitoring (at select sites)

• Pulmonary Function Testing

• Hypoglycemic Event Monitoring

• Laboratory Assessments

Behavioral:
• Nutritional Counseling and Diabetes Education

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Bennington Vermont
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site El Paso Texas
United States Pfizer Investigational Site Hayden Idaho
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New Britain Connecticut
United States Pfizer Investigational Site Norwalk Connecticut
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Syracuse New York

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
Secondary Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
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