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| ID | Type | Description | Link |
|---|---|---|---|
| GALLEX 1 |
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The development program has been terminated
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This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during 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 |
| 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, and non-high-density lipoprotein cholesterol) | ||
| Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol |
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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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| C-reactive protein |
| Central obesity (waist circumference, hip circumference, waist/hip ratio) |
| Columbiana |
| Alabama |
| United States |
| Research Site | Mobile | Alabama | United States |
| Research Site | Carlisle | Arkansas | United States |
| Research Site | Sherwood | Arkansas | United States |
| Research Site | Chula Vista | California | United States |
| Research Site | Escondido | California | United States |
| Research Site | Huntington Beach | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Mission Viejo | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Pasadena | California | United States |
| Research Site | Redondo Beach | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Wheat Ridge | Colorado | United States |
| Research Site | Clearwater | Florida | 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 | West Palm Beach | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Brunswick | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Boise | Idaho | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Witchita | Kansas | United States |
| Research Site | Bossier City | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Kalamazoo | Michigan | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Pahrump | Nevada | United States |
| Research Site | Hamilton | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | White Plains | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Kettering | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Simpsonville | South Carolina | United States |
| Research Site | Morristown | Tennessee | United States |
| Research Site | Corpus Christi | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Burke | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Menomonee Falls | Wisconsin | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Morón | Buenos Aires | Argentina |
| Research Site | Quilmes | Buenos Aires | Argentina |
| Research Site | Córdoba | Córdoba Province | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Salta - Salta | Argentina |
| Research Site | Adelaide | Australia |
| Research Site | Brisbane | Australia |
| Research Site | Cairns | Australia |
| Research Site | Geelong | Australia |
| Research Site | Melbourne | Australia |
| Research Site | Perth | Australia |
| Research Site | Sydney | Australia |
| Research Site | Tasmania | Australia |
| 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 | Calgary | Alberta | Canada |
| Research Site | Coquitlam | British Columbia | Canada |
| Research Site | Surrey | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Bolton | Ontario | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Hastings | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Napanee | Ontario | Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Smith Falls | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Chomedey-Laval | Quebec | Canada |
| Research Site | Laval | Quebec | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Brno | Czechia |
| Research Site | Hodonín | Czechia |
| Research Site | Hradec Králové | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Příbram | Czechia |
| Research Site | Semily | Czechia |
| Research Site | Tábor | Czechia |
| Research Site | Ústí nad Labem | Czechia |
| Research Site | Paide | Estonia |
| Research Site | Pärnu | Estonia |
| Research Site | Tallinn | Estonia |
| Research Site | Tartu | Estonia |
| Research Site | Viljandi | Estonia |
| Research Site | Hämeenlinna | Finland |
| Research Site | Helsinki | Finland |
| Research Site | Imatra | Finland |
| Research Site | Jakobstad | Finland |
| Research Site | Joensuu | Finland |
| Research Site | Kokkola | Finland |
| Research Site | Kouvola | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Lahti | Finland |
| Research Site | Mikkeli | Finland |
| Research Site | Oulu | Finland |
| Research Site | Salo | Finland |
| Research Site | Seinäjoki | Finland |
| Research Site | Tampere | Finland |
| Research Site | Turku | Finland |
| Research Site | Vaasa | Finland |
| Research Site | Vantaa | Finland |
| Research Site | Athens | Greece |
| Research Site | Piraeus | Greece |
| Research Site | Hong Kong | Hong Kong |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Bangalore | India |
| Research Site | Hyderabad | India |
| Research Site | Mumbai | India |
| Research Site | New Delhi | India |
| Research Site | Jakarta | Indonesia |
| Research Site | Malang | Indonesia |
| Research Site | Ashkelon | Israel |
| Research Site | Haifa | Israel |
| Research Site | Holon | Israel |
| Research Site | Jerusalem | Israel |
| Research Site | Rishon LeZiyyon | Israel |
| Research Site | Safed | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Tel Litwinsky | Israel |
| Research Site | Arenzano | Italy |
| Research Site | Chiavari (GE) | Italy |
| Research Site | Chieri | Italy |
| Research Site | Florence | Italy |
| Research Site | Messina | Italy |
| Research Site | Milan | Italy |
| Research Site | Monteccio Emilia | Italy |
| Research Site | Naples | Italy |
| Research Site | Padova | Italy |
| Research Site | Pescara | Italy |
| Research Site | Piacenza | Italy |
| Research Site | Pistoia | Italy |
| Research Site | Reggio Calabria | Italy |
| Research Site | Reggio Emilia | Italy |
| Research Site | Roma | Italy |
| Research Site | Scandiano | Italy |
| Research Site | Udine | Italy |
| Research Site | Daugavpils | Latvia |
| Research Site | Jēkabpils | Latvia |
| Research Site | Madona | Latvia |
| Research Site | Riga | Latvia |
| Research Site | Sigulda | Latvia |
| Research Site | Talsi | Latvia |
| Research Site | Valmiera | Latvia |
| Research Site | Vilnius | Lithuania |
| Research Site | Kubang Kerian | Kota Bharu | Malaysia |
| Research Site | George Town | Malaysia |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Beek en Donk | Netherlands |
| Research Site | Bennebroek | Netherlands |
| Research Site | Deurne | Netherlands |
| Research Site | Huizen | Netherlands |
| Research Site | Losser | Netherlands |
| Research Site | Nijverdal | Netherlands |
| Research Site | Rijswijk | Netherlands |
| Research Site | Roelofarendsveen | Netherlands |
| Research Site | Rotterdam | Netherlands |
| Research Site | The Hague | Netherlands |
| Research Site | Cebu City | Philippines |
| Research Site | Makati | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Marikina City | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Katowice | Ochojec | Poland |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Olsztyn | Poland |
| Research Site | Poznan | Poland |
| Research Site | Radom | Poland |
| Research Site | Rzeszów | Poland |
| Research Site | Sopot | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Toruñ | Poland |
| Research Site | Tychy | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zielona Góra | Poland |
| Research Site | Almada | Portugal |
| Research Site | Amadora | Portugal |
| Research Site | Elvas | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Portalegre | Portugal |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Belgrade | Serbia and Montenegro |
| Research Site | Singapore | Singapore |
| Research Site | Dolný Kubín | Slovakia |
| Research Site | Levice | Slovakia |
| Research Site | Lučenec | Slovakia |
| Research Site | Ľubochňa | Slovakia |
| Research Site | Nové Zámky | Slovakia |
| Research Site | Považská Bystrica | Slovakia |
| Research Site | Šahy | Slovakia |
| Research Site | Trenčín | Slovakia |
| Research Site | Veľký Meder | Slovakia |
| Research Site | Žilina | Slovakia |
| Research Site | Cape Town | South Africa |
| Research Site | Chatsworth | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Gauteng | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Seoul | South Korea |
| Research Site | Suwon | South Korea |
| Research Site | Bern | Switzerland |
| Research Site | Ilanz | Switzerland |
| Research Site | Lausanne | Switzerland |
| Research Site | Monthey | Switzerland |
| Research Site | Zurich | Switzerland |
| Research Site | Aberdeen | United Kingdom |
| Research Site | Atherstone | United Kingdom |
| Research Site | Ayr | United Kingdom |
| Research Site | Bath | United Kingdom |
| Research Site | Belfast | United Kingdom |
| Research Site | Berks | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Bolton | United Kingdom |
| Research Site | Bucks | United Kingdom |
| Research Site | Cardiff | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Liverpool | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Northampton | United Kingdom |
| Research Site | Plymouth | United Kingdom |
| Research Site | Radstock | United Kingdom |
| Research Site | Shrewsbury | United Kingdom |
| Research Site | Surrey | United Kingdom |
| Research Site | West Bromwich | United Kingdom |
| Research Site | Wiltshire | United Kingdom |
| Research Site | Wrexham | United Kingdom |
| Research Site | Hanoi | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| 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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