Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

NCT00370565

Last updated date
Study Location
Pfizer Investigational Site
Irvine, California, 92618, United States
Contact
1-800-718-1021

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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
35-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Asthma, COPD


- Smoking during the previous 6 months

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Advanced Information
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 CenterPfizer
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