A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
NCT00367445
Last updated date
ABOUT THIS STUDY
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2
diabetes mellitus
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
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Diabetes mellitus Type 2
Exclusion Criteria
Show details
- Severe Asthma, severe COPD
- Smoking
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Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus | |||
Official Title ICMJE | A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Oral Agents | |||
Brief Summary | To compare short-term 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: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
| |||
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 | 30 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00367445 | |||
Other Study ID Numbers ICMJE | A2171094 | |||
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 | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |