A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
NCT00391027
Last updated date
ABOUT THIS STUDY
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes
mellitus.
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
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
30 + years
Inclusion Criteria
Show details
- Diabetes Mellitus, Type 2 on oral agents
- Age > 30 years
Exclusion Criteria
Show details
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease
- Smoking
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus® | |||
Official Title ICMJE | A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents | |||
Brief Summary | To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | |||
Actual Enrollment ICMJE | 261 | |||
Original Enrollment ICMJE | 478 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 30 Years and older (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 | Belgium, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00391027 | |||
Other Study ID Numbers ICMJE | A2171084 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |