A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)

TerminadoFase 3ClinicalTrials.gov

ID: NCT00226330Tipo: INTERVENTIONALInicio: 1 de mar de 2005Fin estimado: 1 de dic de 2006

Traducción no disponible, mostrando original

Resumen

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provision of a written informed consent
Men or women who are \>= 18 years of age
Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
Completed the last two visits of the randomized treatment period in GALLANT 6

Criterios de exclusión

Type 1 diabetes
New York Heart Association heart failure Class III or IV
Treatment with chronic insulin
History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
Creatinine levels of above twice the normal range
Creatine kinase of above 3 times the upper limit of normal
Previous enrollment in this long-term extension study
Any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study

Intervenciones

drug

Tesaglitazar

(0.5 or 1 mg)

drug

Pioglitazone

(15, 30 or 45 mg)

Ubicaciones

Research Site

Morón, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba - Córdoba, Argentina

Research Site

Rosario, Argentina

Research Site

Salta - Salta, Argentina

Patrocinadores

PrincipalAstraZeneca

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