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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 01, 2014