Clinical trial NCT00229684: ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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

Primary outcomes:
measure: Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
measure: Glomerular filtration rate (GFR) by iothalamate clearance
measure: Endogenous creatinine clearance
Secondary outcomes:
measure: Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
measure: GFR by iothalamate clearance
measure: Endogenous creatinine clearance
measure: The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
measure: The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
measure: The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
measure: The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
measure: 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.
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Flushing
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Cheswick
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Midland
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Gig Harbor
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: