A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus


Last updated date
Study Location
Pfizer Investigational Site
Chula Vista, California, , United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diabetes mellitus Type 2

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

- Smoking


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Advanced Information
Descriptive Information
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
  • Drug: Inhaled Human Insulin (Exubera)
  • Drug: Insulin Glargine (Lantus)
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 21, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus Type 2

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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