ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
This study has been terminated.
(The development program has been terminated)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00229684
First received: September 28, 2005
Last updated: August 29, 2011
Last verified: August 2011
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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
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 May 23, 2013