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NCT00333723

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

Completed Phase 4 Last updated 9 October 2017
What this trial tests

Phase 4 trial testing Rosiglitazone in Diabetes Mellitus, Type 2 in 245 participants. Completed in 6 January 2003.

Timeline
28 July 2000
Primary endpoint
6 January 2003
6 January 2003

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment245
Start date28 July 2000
Primary completion6 January 2003
Estimated completion6 January 2003

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

21 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An overview on medicinal perspective of thiazolidine-2,4-dione: A remarkable scaffold in the treatment of type 2 diabetes.
    Bansal G, Thanikachalam PV, Maurya RK, Chawla P, et al · · 2020 · cited 49× · PMID 32154036 · DOI 10.1016/j.jare.2020.01.008

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Other trials of Rosiglitazone

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00333723.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing