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

Rosiglitazone and Insulin in T1DM Adolescents

Phase 4

Completed

Conditions: Type 1 Diabetes
Puberty: >Tanner 2 Breast Development or Testis >4ml

First Posted Date: 2006-09-06

Last Posted Date: 2006-09-06

Lead Sponsor: The University of New South Wales

Target Recruit Count: 32

Registration Number: NCT00372086

Locations: 🇦🇺
Sydney Children's Hospital, Sydney, New South Wales, Australia

11ß-HSD1 and Metabolic Syndrome

Phase 2

Completed

Conditions: Impaired Glucose Tolerance
Metabolic Syndrome

Interventions: Drug: rosiglitazone

First Posted Date: 2006-08-31

Last Posted Date: 2018-01-16

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 24

Registration Number: NCT00370305

Locations: 🇩🇪
Charite, Campus Benjamin Franklin, Berlin, Germany

Rosiglitazone Effect on Mitochondria and Lipoatrophy

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: Placebo
Drug: Rosiglitazone

First Posted Date: 2006-08-23

Last Posted Date: 2017-02-06

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

Target Recruit Count: 71

Registration Number: NCT00367744

Locations: 🇺🇸
Cleveland Clinc Foundation, Cleveland, Ohio, United States
🇺🇸
University Hospitals of Cleveland/Case Western Reserve University, Cleveland, Ohio, United States

Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

Phase 4

Completed

Conditions: Metabolic Syndrome
Insulin Resistance

First Posted Date: 2006-08-15

Last Posted Date: 2012-11-22

Lead Sponsor: University of Colorado, Denver

Registration Number: NCT00364221

Locations: 🇺🇸
University of Colorado at Denver and Health Sciences Center General Clinical Research Center, Denver, Colorado, United States

Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Phase 3

Terminated

Conditions: Dyslipidemia
Glucose Metabolism Disorder

Interventions: Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
Drug: Rosiglitazone

First Posted Date: 2006-08-09

Last Posted Date: 2008-06-27

Lead Sponsor: Solvay Pharmaceuticals

Target Recruit Count: 88

Registration Number: NCT00361868

Locations: 🇩🇪
Site 405, Berlin, Germany
🇭🇷
Site105, Pula, Croatia
🇭🇷
Site102, Rijeka, Croatia

and more 67 locations

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Phase 3

Completed

Conditions: Non-Insulin-Dependent Diabetes Mellitus

First Posted Date: 2006-08-01

Last Posted Date: 2009-05-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 544

Registration Number: NCT00359112

Locations: 🇬🇧
GSK Investigational Site, Sheffield, United Kingdom

Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

First Posted Date: 2006-07-31

Last Posted Date: 2011-01-11

Lead Sponsor: Sanofi

Target Recruit Count: 220

Registration Number: NCT00358124

Locations: 🇺🇸
Sanofi-Aventis, Bridgewater, New Jersey, United States

Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: sitagliptin
Drug: rosiglitazone
Drug: metformin
Drug: glipizide

First Posted Date: 2006-07-11

Last Posted Date: 2017-05-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 262

Registration Number: NCT00350779

Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Phase 3

Terminated

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: inhaled human insulin
Drug: rosiglitazone
Drug: metformin

First Posted Date: 2006-07-06

Last Posted Date: 2017-03-01

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 301

Registration Number: NCT00348712

Locations: 🇬🇧
Novo Nordisk Investigational Site, York, United Kingdom

Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study

Phase 4

Terminated

Conditions: Coronary Artery Disease

Interventions: Drug: AVANDAMET

First Posted Date: 2006-06-23

Last Posted Date: 2011-03-17

Lead Sponsor: Intermountain Health Care, Inc.

Target Recruit Count: 200

Registration Number: NCT00343395

Locations: 🇺🇸
Intermountain Medical Center, Murray, Utah, United States

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