ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
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ClinicalTrials.gov Identifier: NCT00229684 |
Recruitment Status
:
Terminated
(The development program has been terminated)
First Posted
: September 30, 2005
Last Update Posted
: August 30, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Tesaglitazar Drug: pioglitazone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | A 24-week, Randomised, Parallel-Group, Multi-Centre, Open-Label Study of the Renal Effects of Tesaglitazar in Patients With Type 2 Diabetes Mellitus |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

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Drug: Tesaglitazar
- Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
- Glomerular filtration rate (GFR) by iothalamate clearance
- Endogenous creatinine clearance
- Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
- GFR by iothalamate clearance
- Endogenous creatinine clearance
- The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
- The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
- The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
- The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
- The safety and tolerability of tesaglitazar in type 2 diabetics by assessments of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, body weight, and physical examination.

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229684
United States, California | |
Research Site | |
Pasadena, California, United States | |
United States, District of Columbia | |
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Washington, District of Columbia, United States | |
United States, Florida | |
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Gainesville, Florida, United States | |
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Miami, Florida, United States | |
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Orlando, Florida, United States | |
United States, Georgia | |
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Augusta, Georgia, United States | |
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Columbus, Georgia, United States | |
United States, Louisiana | |
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New Orleans, Louisiana, United States | |
United States, Nevada | |
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Reno, Nevada, United States | |
United States, New York | |
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Flushing, New York, United States | |
United States, North Carolina | |
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Durham, North Carolina, United States | |
United States, Ohio | |
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Cleveland, Ohio, United States | |
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Columbus, Ohio, United States | |
United States, Oklahoma | |
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Tulsa, Oklahoma, United States | |
United States, Pennsylvania | |
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Cheswick, Pennsylvania, United States | |
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Philadelphia, Pennsylvania, United States | |
United States, Tennessee | |
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Nashville, Tennessee, United States | |
United States, Texas | |
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Midland, Texas, United States | |
Research Site | |
San Antonio, Texas, United States | |
United States, Washington | |
Research Site | |
Gig Harbor, Washington, United States | |
Research Site | |
Seattle, Washington, United States |
Study Director: | Galida Medical Science Director, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00229684 History of Changes |
Other Study ID Numbers: |
D6160C00040 |
First Posted: | September 30, 2005 Key Record Dates |
Last Update Posted: | August 30, 2011 |
Last Verified: | August 2011 |
Keywords provided by AstraZeneca:
Type 2 Diabetes |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |