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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:
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150410
First received: September 6, 2005
Last updated: October 28, 2008
Last verified: October 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150410

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00150410     History of Changes
Other Study ID Numbers: A2171017
Study First Received: September 6, 2005
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013