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US Inhaled Insulin Dose Titration Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246623
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : February 8, 2008
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Exubera (inhaled insulin) Procedure: 8-point glucose diary (to assess pre- and post prandial glucoses) Procedure: Meal Tolerance Test Procedure: 24-hour continuous glucose monitoring (at select sites) Procedure: Pulmonary Function Testing Procedure: Hypoglycemic Event Monitoring Procedure: Laboratory Assessments Behavioral: Nutritional Counseling and Diabetes Education Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246623


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
United States, Connecticut
Pfizer Investigational Site
New Britain, Connecticut, United States
Pfizer Investigational Site
Norwalk, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Hayden, Idaho, United States
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, New York
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
El Paso, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00246623    
Other Study ID Numbers: A2171067
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: May 2007
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs