AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333723
First received: June 2, 2006
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.


Condition Intervention Phase
Non-insulin-dependent Diabetes Mellitus
Drug: Rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24-Week Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AVANDIA (8mg Once Daily) in Combination With Glyburide in African American and Hispanic Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glyburide Monotherapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c). [ Time Frame: 24 Weeks ]

Secondary Outcome Measures:
  • Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates. [ Time Frame: 24 Weeks ]

Enrollment: 245
Study Start Date: July 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • African American or Hispanic.
  • Type 2 diabetes mellitus.
  • FPG>=140mg/dL plus HbA1c>=7.5% whilst receiving SU monotherapy.

Exclusion criteria:

  • Patients who use insulin.
  • Clinically significant liver, kidney or heart disease, including high blood pressure.
  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: NCT00333723

  Hide Study Locations
Locations
United States, Alabama
GSK Clinical Trials Call Center
Birmingham, Alabama, United States, 35233
United States, Arizona
GSK Clinical Trials Call Center
Mesa, Arizona, United States, 85202
United States, Arkansas
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72211
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72205
United States, California
GSK Clinical Trials Call Center
Anaheim, California, United States, 92801-2811
GSK Clinical Trials Call Center
Fresno, California, United States, 93721
GSK Clinical Trials Call Center
Harbor City, California, United States, 90710
GSK Clinical Trials Call Center
San Diego, California, United States, 92102
GSK Clinical Trials Call Center
San Diego, California, United States, 92103
GSK Clinical Trials Call Center
Spring Valley, California, United States, 91978
GSK Clinical Trials Call Center
Torrance, California, United States, 90503
United States, Colorado
GSK Clinical Trials Call Center
Colorado Springs, Colorado, United States, 80903
United States, District of Columbia
GSK Clinical Trials Call Center
Washington, District of Columbia, United States, 20060
United States, Florida
GSK Clinical Trials Call Center
Miami, Florida, United States, 33133
GSK Clinical Trials Call Center
Orlando, Florida, United States, 32807
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60612-3824
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60607
United States, Louisiana
GSK Clinical Trials Call Center
Kenner, Louisiana, United States, 70062
United States, Maryland
GSK Clinical Trials Call Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Clinical Trials Call Center
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Clinical Trials Call Center
Detroit, Michigan, United States, 48201
GSK Clinical Trials Call Center
Oak Park, Michigan, United States, 48237
United States, Missouri
GSK Clinical Trials Call Center
Florissant, Missouri, United States, 63031
United States, Nevada
GSK Clinical Trials Call Center
Las Vegas, Nevada, United States, 89102
United States, New Mexico
GSK Clinical Trials Call Center
Albuquerque, New Mexico, United States, 87131-5271
United States, New York
GSK Clinical Trials Call Center
Buffalo, New York, United States, 14209
GSK Clinical Trials Call Center
New York, New York, United States, 10032-3784
GSK Clinical Trials Call Center
New York, New York, United States, 10029
United States, North Carolina
GSK Clinical Trials Call Center
Durham, North Carolina, United States, 27710
GSK Clinical Trials Call Center
Gastonia, North Carolina, United States, 28054
United States, Ohio
GSK Clinical Trials Call Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73111
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
GSK Clinical Trials Call Center
Fleetwood, Pennsylvania, United States, 19522
GSK Clinical Trials Call Center
Upper Darby, Pennsylvania, United States, 19082
United States, Rhode Island
GSK Clinical Trials Call Center
East Providence, Rhode Island, United States, 02914
United States, South Carolina
GSK Clinical Trials Call Center
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Clinical Trials Call Center
Austin, Texas, United States, 78750
GSK Clinical Trials Call Center
Houston, Texas, United States, 77030
GSK Clinical Trials Call Center
Midland, Texas, United States, 79705
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78221
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78237
Puerto Rico
GSK Clinical Trials Call Center
Carolina, Puerto Rico, 00983
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: GSK Clinical Trials, MD Glaxosmithline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00333723     History of Changes
Other Study ID Numbers: 49653/143
Study First Received: June 2, 2006
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Rosiglitazone
Type 2 Diabetes Mellitus
Glyburide
African American
Hispanic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014