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

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: Rosiglitazone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: Glaxosmithline

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c).

Secondary outcome: Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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.

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Starting date: July 2000
Last updated: August 10, 2007