GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes

Stopped early · Phase 3

Conditions studied: Type 2 Diabetes

In brief

This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Key facts

Study ID

NCT00252876

Run by

AstraZeneca

People needed

2000

Starts

2005-03-01

Expected to finish

2007-01-01

Last updated by the study team

2008-03-17

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 randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.

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
• 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 — Columbiana, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Carlisle, Arkansas, United States
• Research Site — Sherwood, Arkansas, 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 — 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 — Honolulu, Hawaii, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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