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The development program has been terminated
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This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | (0.5 or 1 mg) |
| |
| Pioglitazone | Drug | (15, 30 or 45 mg) |
|
| 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 |
|---|---|---|
| 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) |
| Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36) |
| Columbiana |
| Alabama |
| United States |
| Research Site | Mobile | Alabama | United States |
| Research Site | Chandler | Arizona | United States |
| Research Site | Mesa | Arizona | United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Sierra Vista | Arizona | United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Jonesboro | Arkansas | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Searcy | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Carmichael | California | United States |
| Research Site | Dinuba | California | United States |
| Research Site | Elk Grove | California | United States |
| Research Site | Encinitas | California | United States |
| Research Site | Encino | California | United States |
| Research Site | Fresno | California | United States |
| Research Site | Greenbrae | California | United States |
| Research Site | Loma Linda | California | United States |
| Research Site | Long Beach | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Mission Viejo | California | United States |
| Research Site | Northridge | California | United States |
| Research Site | Pasadena | California | United States |
| Research Site | Redondo Beach | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Santa Monica | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Tustin | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | West Hills | California | United States |
| Research Site | Newark | Delaware | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Brandon | Florida | United States |
| Research Site | Cooper City | Florida | United States |
| Research Site | Delray Beach | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Melbourne | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Ocoee | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Plantation | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Columbus | Georgia | United States |
| Research Site | Dunwoody | Georgia | United States |
| Research Site | Berwyn | Illinois | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Elk Grove Village | Illinois | United States |
| Research Site | Gurnee | Illinois | United States |
| Research Site | Melrose Park | Illinois | United States |
| Research Site | North Chicago | Illinois | United States |
| Research Site | Peoria | Illinois | United States |
| Research Site | Sterling | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Des Moines | Iowa | United States |
| Research Site | Waterloo | Iowa | United States |
| Research Site | Topeka | Kansas | United States |
| Research Site | Witchita | Kansas | United States |
| Research Site | Lexington | Kentucky | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Slidell | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Columbia | Maryland | United States |
| Research Site | Haverhill | Massachusetts | United States |
| Research Site | Petoskey | Michigan | United States |
| Research Site | Excelsior Springs | Missouri | United States |
| Research Site | Richmond Heights | Missouri | United States |
| Research Site | Rolla | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | North Las Vegas | Nevada | United States |
| Research Site | Pahrump | Nevada | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Pleasantville | New Jersey | United States |
| Research Site | Manlius | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Olean | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Asheville | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Lakewood | 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 | Erie | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Reading | Pennsylvania | United States |
| Research Site | Warminster | Pennsylvania | United States |
| Research Site | West Chester | Pennsylvania | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Carrollton | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | North Richland Hills | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Gig Harbor | Washington | United States |
| Research Site | Huntington | West Virginia | United States |
| Research Site | Morón | Buenos Aires | Argentina |
| Research Site | Quilmes | Buenos Aires | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Córdoba - Córdoba | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Salta - Salta | Argentina |
| Research Site | Curitiba | Brazil |
| Research Site | Fortaleza | Brazil |
| Research Site | Goiânia | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Ribeirão Preto | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Abbotsford British Columbia | British Columbia | Canada |
| Research Site | Chilliwack | British Columbia | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Victoria | British Columbia | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Dartmouth | Nova Scotia | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Truro | Nova Scotia | Canada |
| Research Site | Windsor | Nova Scotia | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | Niagara Falls | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Scarborough Village | Ontario | Canada |
| Research Site | St. Catharines | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Chicoutimi | Quebec | Canada |
| Research Site | Longueuil | Quebec | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Trois-Rivières | Quebec | Canada |
| Research Site | Helsinki | Finland |
| Research Site | Jakobstad | Finland |
| Research Site | Kauniainen | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Pori | Finland |
| Research Site | Tampere | Finland |
| Research Site | Guadalajara, Jalisco. | Mexico |
| Research Site | México, D.F. | Mexico |
| Research Site | Nuevo León, Monterrey | Mexico |
| Research Site | Puebla, Mexico | Mexico |
| Research Site | Torreón | Mexico |
| Research Site | Zapopan | Mexico |
| Research Site | Belfast | United Kingdom |
| Research Site | Cardiff | United Kingdom |
| Research Site | Co Antrim N Ireland | United Kingdom |
| Research Site | Co. Wexford, Ireland | United Kingdom |
| Research Site | Dublin | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Kent | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Mid Glamorgan | United Kingdom |
| Research Site | Pembrokeshire | United Kingdom |
| Research Site | Plymouth | United Kingdom |
| Research Site | Reading | United Kingdom |
| Research Site | Surrey | United Kingdom |
| Research Site | Wiltshire | United Kingdom |
| 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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