GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

Stopped early · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.

Key facts

Study ID

NCT00242372

Run by

AstraZeneca

People needed

370

Starts

2004-08-01

Expected to finish

2006-03-01

Last updated by the study team

2009-04-22

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
• Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day

You may not qualify if…

• Type 1 diabetes
• New York Heart Association heart failure Class III or IV
• Treatment with any thiazolidinedione class of antidiabetic agents
• 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 — Phoenix, Arizona, United States
• Research Site — Tuscson, 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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