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

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00229684
First received: September 28, 2005
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Tesaglitazar
Drug: pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tesaglitazar
    2 mg once daily in oral form
    Other Name: Galida
    Drug: pioglitazone
    45 mg once daily in oral form
    Other Name: Actos
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229684

Locations
United States, California
Research Site
Pasadena, California, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Augusta, Georgia, United States
Research Site
Columbus, Georgia, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Nevada
Research Site
Reno, Nevada, United States
United States, New York
Research Site
Flushing, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States
United States, Pennsylvania
Research Site
Cheswick, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Galida Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00229684     History of Changes
Other Study ID Numbers: D6160C00040
Study First Received: September 28, 2005
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014