GALLANT 6 Tesaglitazar vs. Pioglitazone

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

Key facts

Study ID: NCT00214565
Run by: AstraZeneca
People needed: 1450
Starts: 2004-08-01
Expected to finish: 2006-10-01
Last updated by the study team: 2010-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of a written informed consent
Men or women who are ³18 years of age
Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
Diagnosed with type 2 diabetes
Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

You may not qualify if…

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, neutropenia (low white blood cells)
Creatinine levels above twice the normal range
Creatine kinase above 3 times the upper limit of normal
Received any investigational product in other clinical studies within 12 weeks
Any clinically significant abnormality identified on 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

Where it is running

Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Córdoba, Argentina
Research Site — Moron- Buenos Aires, Argentina
Research Sites — Quilmes - Buenos Aires, Argentina
Research Site — Rosario, Argentina
Research Site — Salta, Argentina
Research Site — Curitiba, Brazil
Research Site — Edmonton, Alberta, Canada
Research Site — Abbotsford British Columbia, British Columbia, Canada
Research Site — Chilliwack, British Columbia, Canada
Research Site — Vancouver, British Columbia, Canada
Research Site — Victoria, British Columbia, Canada
Research Site — Dartmouth, Nova Scotia, Canada
Research Site — Halifax, Nova Scotia, Canada
Research Site — Truro, Nova Scotia, Canada
Research Site — Windsor, Nova Scotia, Canada
Research Site — Brampton, Ontario, Canada
Research Site — Etobicoke, Ontario, Canada
Research Site — Kingston, Ontario, Canada
Research Site — Niagara Falls, Ontario, Canada
Research Site — Oshawa, Ontario, Canada
Research Site — Scarborough Village, Ontario, Canada
Research Site — St. Catharines, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Altoona, Pennsylvania, United States

Full record on ClinicalTrials.gov

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