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Trial record 1 of 1 for:    NCT00246623
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US Inhaled Insulin Dose Titration Study

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ClinicalTrials.gov Identifier: NCT00246623
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : February 8, 2008
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE October 31, 2005
Last Update Posted Date February 8, 2008
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
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.
Change History Complete list of historical versions of study NCT00246623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
Key secondary endpoints include change from baseline in A1C, fasting and 2 hour post prandial glucose, 24-hour mean glucose values measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. The prevalance and severity of
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE US Inhaled Insulin Dose Titration Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 28, 2005)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00246623
Other Study ID Numbers  ICMJE A2171067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP