AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333723
First received: June 2, 2006
Last updated: February 11, 2013
Last verified: February 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333723
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| 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 June 18, 2013