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The development program has been terminated
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This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | 0.5 in combination with insulin (with or without other oral antidiabetic drugs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | ||
| Laboratory variables | ||
| Physical examination | ||
| Cardiac evaluation | ||
| Hypoglycemic events | ||
| Electrocardiogram | ||
| Vital signs (blood pressure and pulse) | ||
| Body weight |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c | ||
| Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Galida Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C |
| C-reactive protein (CRP) |
| Central obesity (waist circumference, hip circumference, waist/hip ratio) |
| Phoenix |
| Arizona |
| United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Fresno | California | United States |
| Research Site | Greenbrae | California | United States |
| Research Site | La Jolla | California | United States |
| Research Site | Northridge | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Santa Monica | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | West Hills | California | United States |
| Research Site | Waterbury | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Palm Harbor | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Dunwoody | Georgia | United States |
| Research Site | Boise | Idaho | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Chicago Heights | Illinois | United States |
| Research Site | Gurnee | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Cadillac | Michigan | United States |
| Research Site | Richmond Heights | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | North Las Vegas | Nevada | United States |
| Research Site | Pahrump | Nevada | United States |
| Research Site | Dover | New Hampshire | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New Hyde Park | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Wilmington | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Kettering | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Altoona | Pennsylvania | United States |
| Research Site | Cheswick | Pennsylvania | United States |
| Research Site | Erie | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Corpus Christi | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Fort Worth | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Roseland | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Renton | Washington | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Madison | Wisconsin | 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 |
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