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US Inhaled Insulin Dose Titration Study

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NCT00246623

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female, age >= 18 years and 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Type 1 diabetes

- Smoking within the past 6 months or significant pulmonary diseases

NCT00246623
Pfizer
Completed
US Inhaled Insulin Dose Titration Study

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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US Inhaled Insulin Dose Titration Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00246623
A2171067
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Sanofi
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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