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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333723
• Other study ID #: 49653/143
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2006
• Last updated: October 5, 2017
• Start date: July 28, 2000
• Est. completion date: January 6, 2003

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 6, 2003
• Est. primary completion date: January 6, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (2)

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

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 pres

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c).		24 Weeks
Secondary	Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates.		24 Weeks

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