Study Stopped
The development program has been terminated
ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
A 24-week, Randomised, Parallel-Group, Multi-Centre, Open-Label Study of the Renal Effects of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
100
1 country
21
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Sep 2004
Typical duration for phase_2 diabetes-mellitus-type-2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedAugust 30, 2011
August 1, 2011
1.7 years
September 28, 2005
August 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Galida Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
September 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
August 30, 2011
Record last verified: 2011-08