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

Last updated on December 5, 2019

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Study Location
Pfizer Investigational Site
Chula Vista, California, United States
Contact
1-800-718-1021
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes mellitus Type 2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Severe Asthma, severe COPD

- Smoking

NCT00367445
Pfizer
Completed
A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus

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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 SummaryTo compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus
Detailed DescriptionNot 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)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

BY EMAIL

Contact

[email protected]

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