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The development program has been terminated
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | 2 mg once daily in oral form |
| |
| pioglitazone | Drug | 45 mg once daily in oral form |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galida Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pasadena | California | United States | |||
| Research Site |
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| 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. |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C501413 | tesaglitazar |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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