GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.

Key facts

Study ID

NCT00229710

Run by

AstraZeneca

People needed

270

Starts

2005-02-01

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 >= 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 9

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, 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 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 — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Fresno, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Northridge, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — West Hills, California, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, 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 — Orlando, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Dunwoody, Georgia, United States
• Research Site — Boise, Idaho, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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