A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

NCT00391027

Last updated date
Study Location
Pfizer Investigational Site
Bornem, , 2800, Belgium
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
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes Mellitus, Type 2 on oral agents

- Age > 30 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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
  • Drug: Insulin Glargine (Lantus®)
    Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
  • Drug: Inhaled Human Insulin (Exubera®)
    Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
Study Arms  ICMJE
  • Active Comparator: Insulin Glargine (Lantus®)
    Intervention: Drug: Insulin Glargine (Lantus®)
  • Active Comparator: Inhaled Human Insulin (Exubera®)
    Intervention: Drug: Inhaled Human Insulin (Exubera®)
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
 (submitted: September 15, 2009)
261
Original Enrollment  ICMJE
 (submitted: October 19, 2006)
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:

  • Diabetes Mellitus, Type 2 on oral agents
  • Age > 30 years

Exclusion Criteria:

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