ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)

Stopped early · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a 2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week follow-up period

Key facts

Study ID

NCT00229684

Run by

AstraZeneca

People needed

100

Starts

2004-09-01

Expected to finish

2006-06-01

Last updated by the study team

2011-08-30

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of a written informed consent
• Men or women who are >=45 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 — Pasadena, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Columbus, Georgia, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Reno, Nevada, United States
• Research Site — Flushing, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Tulsa, Oklahoma, United States
• Research Site — Cheswick, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Midland, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Gig Harbor, Washington, United States
• Research Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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