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Trial record 1 of 1 for:    NCT00370565
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Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

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ClinicalTrials.gov Identifier: NCT00370565
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : February 13, 2007
Sponsor:
Collaborators:
Sanofi
Nektar Therapeutics
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 29, 2006
First Posted Date  ICMJE August 31, 2006
Last Update Posted Date February 13, 2007
Study Start Date  ICMJE June 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2006)
  • The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2006)
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization. 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.
Change History Complete list of historical versions of study NCT00370565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2006)
  • 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)
  • Meal glucose response measured at Week -1 and at Week 12;
  • These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
  • not the subject’s home glucose monitoring results.
  • Comparison of 24-hour home glucose profiles.
  • 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.
  • A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2006)
  • 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)
  • Meal glucose response measured at Week -1 and at Week 12
  • These results for efficacy are measured in the lab using plasma samples collected during clinic visits, not the subject’s home glucose monitoring results.
  • Comparison of 24-hour home glucose profiles.
  • 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.
  • A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Official Title  ICMJE 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.
Brief 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.
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: Inhaled Human Insulin
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: August 29, 2006)
345
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00370565
Other Study ID Numbers  ICMJE 217-109
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
  • Nektar Therapeutics
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2007

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