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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333723
First received: June 2, 2006
Last updated: September 22, 2016
Last verified: September 2016
  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
Diabetes Mellitus, Type 2
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
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Abstract: Rosiglitazone Added to Sulfonylurea Improves Glycemic Control and Insulin Sensitivity in African American and Hispanic American Subjects with Type 2 Diabetes, CAMPBELL, JOHN C.; GOULD, ERROL M.; WATERHOUSE, BRIAN R.; COBITZ, ALEXANDER R. Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
Campbell JC, Gould EM, Waterhouse BR, Cobitz AR. Rosiglitazone added to sulfonylurea improves glycemic control and insulin sensitivity in African American and Hispanic American subjects with type 2 diabetes. Diabetes 2004;53(Suppl 2):A154. Poster 645 presented at ADA.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 49653/143
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00333723     History of Changes
Other Study ID Numbers: 49653/143 
Study First Received: June 2, 2006
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Rosiglitazone
Glyburide
Type 2 Diabetes Mellitus
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

ClinicalTrials.gov processed this record on September 26, 2016