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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229684
• Other study ID #: D6160C00040
• Status: Terminated
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: August 29, 2011
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Tesaglitazar
2 mg once daily in oral form
• pioglitazone
45 mg once daily in oral form

Locations

Country	Name	City	State
United States	Research Site	Augusta	Georgia
United States	Research Site	Cheswick	Pennsylvania
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Durham	North Carolina
United States	Research Site	Flushing	New York
United States	Research Site	Gainesville	Florida
United States	Research Site	Gig Harbor	Washington
United States	Research Site	Miami	Florida
United States	Research Site	Midland	Texas
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Orlando	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Reno	Nevada
United States	Research Site	San Antonio	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
Primary	Glomerular filtration rate (GFR) by iothalamate clearance
Primary	Endogenous creatinine clearance
Secondary	Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
Secondary	GFR by iothalamate clearance
Secondary	Endogenous creatinine clearance
Secondary	The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
Secondary	The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
Secondary	The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
Secondary	The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
Secondary	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.