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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333723

Enrollment

245

Registered

2006-06-06

Start date

2000-07-28

Completion date

2003-01-06

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Rosiglitazone, Glyburide, Type 2 Diabetes Mellitus, African American, Hispanic

Brief summary

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.

Interventions

DRUGRosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c).	24 Weeks

Secondary

Measure	Time frame
Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates.	24 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026