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

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ClinicalTrials.gov Identifier: NCT00150410
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 31, 2008
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Inhaled insulin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
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
Study Start Date : January 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources




Primary Outcome Measures :
  1. Glycosylated hemoglobin

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


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

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00150410     History of Changes
Other Study ID Numbers: A2171017
First Posted: September 8, 2005    Key Record Dates
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