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

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NCT00391027

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bornem, , 2800 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00391027
Pfizer
Completed
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

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A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
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
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • Active Comparator: Insulin Glargine (Lantus®)
    Intervention: Drug: Insulin Glargine (Lantus®)
  • Active Comparator: Inhaled Human Insulin (Exubera®)
    Intervention: Drug: Inhaled Human Insulin (Exubera®)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease
  • Smoking
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Switzerland
 
 
NCT00391027
A2171084
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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