GALLANT 5 Tesaglitazar Versus Metformin

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Key facts

Study ID

NCT00214591

Run by

AstraZeneca

People needed

580

Starts

2004-08-01

Expected to finish

2006-12-01

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 — Columbiana, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Carlisle, Arizona, United States
• Research Center — Sherwood, Arizona, United States
• Research Site — Chula Vista, California, United States
• Research Site — Escondido, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Orange, California, United States
• Research Site — Pasadena, California, United States
• Research Site — Pomona, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Wheat Ridge, Colorado, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Brunswick, Georgia, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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