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A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

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ClinicalTrials.gov Identifier: NCT00134147
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : April 17, 2008
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer

Study Description
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Brief Summary:
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Inhaled Insulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents
Study Start Date : April 2005
Actual Study Completion Date : May 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Glycosylated hemoglobin

Secondary Outcome Measures :
  1. Percent of patients achieving good control of fasting glucose and lipids
  2. Rate of hypoglycemia
  3. Changes in body weight
  4. Patient satisfaction
  5. Safety based on adverse events reported and laboratory tests

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Failing two or more oral anti-diabetic agents

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134147


Locations
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Sponsors and Collaborators
Pfizer
Sanofi
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00134147    
Other Study ID Numbers: A2171018
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs