A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
NCT00134147
Last updated date
ABOUT THIS STUDY
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes
who are not well controlled on 2 or more oral anti-diabetic agents
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Diabetes Mellitus
Sex
Females and Males
Age
35-80 years
Inclusion Criteria
Show details
- Diabetes mellitus Type 2
- Failing two or more oral anti-diabetic agents
Exclusion Criteria
Show details
- Asthma, COPD
- Smoking
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control | |||
Official Title ICMJE | A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents | |||
Brief Summary | To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more 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 | |||
Intervention ICMJE | Drug: Inhaled Insulin | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. | |||
* 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 | 1100 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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, France, Germany, Italy, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00134147 | |||
Other Study ID Numbers ICMJE | A2171018 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |