Rosiglitazone

Generic Name: Rosiglitazone

Brand Names: Avandamet, Avandia

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₉N_₃O_₃S

CAS Number: 122320-73-4

Unique Ingredient Identifier: 05V02F2KDG

Background: Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It is marketed by the pharmaceutical company GlaxoSmithKline as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Like other thiazolidinediones, the mechanism of action of rosiglitazone is by activation of the intracellular receptor class of the peroxisome proliferator-activated receptors (PPARs), specifically PPARγ. Rosiglitazone is a selective ligand of PPARγ, and has no PPARα-binding action. Apart from its effect on insulin resistance, it appears to have an anti-inflammatory effect: nuclear factor kappa-B (NFκB) levels fall and inhibitor (IκB) levels increase in patients on rosiglitazone. Recent research has suggested that rosiglitazone may also be of benefit to a subset of patients with Alzheimer's disease not expressing the ApoE4 allele. This is the subject of a clinical trial currently underway.

Indication: Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions: Type 2 Diabetes Mellitus

Associated Therapies: -

Clinical Trials

The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial

Phase 3

Completed

Conditions: Cardiovascular Disease
Glucose Metabolism Disorders
Impaired Glucose Tolerance

First Posted Date: 2004-11-08

Last Posted Date: 2009-11-10

Lead Sponsor: Gerstein, Hertzel, MD

Target Recruit Count: 5000

Registration Number: NCT00095654

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type II

Interventions: Drug: Metformin
Behavioral: Lifestyle Program
Drug: Rosiglitazone

First Posted Date: 2004-04-12

Last Posted Date: 2021-07-30

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Target Recruit Count: 699

Registration Number: NCT00081328

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
George Washington University Biostatistics Center, Rockville, Maryland, United States
🇺🇸
Columbia University Medical Center, New York, New York, United States

and more 13 locations

A Trial of Rosiglitazone for Ulcerative Colitis

Phase 2

Completed

Conditions: Ulcerative Colitis
Inflammatory Bowel Disease

Interventions: Drug: Placebo
Drug: Rosiglitazone

First Posted Date: 2003-07-18

Last Posted Date: 2018-01-16

Lead Sponsor: James Lewis

Target Recruit Count: 105

Registration Number: NCT00065065

Locations: 🇺🇸
Wake Research Associates, Raleigh, North Carolina, United States
🇺🇸
Capitol Gastroenterology Consultants, Silver Spring, Maryland, United States
🇺🇸
University Hospitals of Cleveland, Cleveland, Ohio, United States

and more 10 locations

Efficacy and Safety In Poorly Controlled Type 2 Diabetics

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

First Posted Date: 2002-08-30

Last Posted Date: 2017-10-09

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 142

Registration Number: NCT00044460

Endothelial Dysfunction as a Risk Factor in HIV Study

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2002-06-07

Last Posted Date: 2008-03-04

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 75

Registration Number: NCT00039663

Locations: 🇺🇸
National Institutes of Health Clinical Center (CC), Bethesda, Maryland, United States

Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Insulin
Drug: Glimepiride
Drug: Rosiglitazone
Drug: Metformin

First Posted Date: 2002-03-22

Last Posted Date: 2017-03-30

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 1791

Registration Number: NCT00032487

Locations: 🇺🇸
Southern Arizona VA Health Care System, Tucson, Tucson, Arizona, United States
🇺🇸
VA Medical Center, Long Beach, Long Beach, California, United States
🇺🇸
Edward Hines, Jr. VA Hospital, Hines, Illinois, United States

and more 18 locations

Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities

Not Applicable

Completed

Conditions: HIV Infections
Lipodystrophy
Hyperinsulinemia

First Posted Date: 2001-08-31

Last Posted Date: 2013-07-22

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 105

Registration Number: NCT00015691

Locations: 🇺🇸
Johns Hopkins Hosp, Baltimore, Maryland, United States
🇺🇸
Ohio State Univ Hosp Clinic, Columbus, Ohio, United States
🇺🇸
Vanderbilt Univ Med Ctr, Nashville, Tennessee, United States

and more 31 locations