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Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150410
First Posted: September 8, 2005
Last Update Posted: October 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
Pfizer
  Purpose
  • Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
  • Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Condition Intervention Phase
Diabetes Mellitus Drug: Inhaled insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glycosylated hemoglobin

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose. Other secondary efficacy
  • endpoints include, body weight, patient reported outcomes, incidence and severity
  • of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
  • insufficient clinical response.

Enrollment: 626
Study Start Date: January 2003
Study Completion Date: June 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated and on a stable doses of drugs for the preceding two (2) months

Exclusion Criteria:

  • Type 1 Diabetes
  • Smoking
  Contacts and Locations
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): NCT00150410


  Show 120 Study Locations
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00150410     History of Changes
Other Study ID Numbers: A2171017
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: October 31, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs