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The development program has been terminated
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This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GALIDA | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) |
| Measure | Description | Time Frame |
|---|---|---|
| The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide | ||
| Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model | ||
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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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| Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co |
| C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio |
| FPG, homeostasis assessment model, insulin, proinsulin, C-peptide |
| Tumor necrosis factor-alpha, intracellular adhesion molecule-1 |
| Fibrinogen |
| Urinary albumin excretion |
| Waist/hip ratio |
| Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values |
| Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C |
| Pharmacokinetics of tesaglitazar |
| Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination |
| Columbiana |
| Alabama |
| United States |
| Research Site | Mobile | Alabama | United States |
| Research Site | Carlisle | Arizona | United States |
| Research Center | Sherwood | Arizona | 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 | Pomona | 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 | Carollton | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Boise | Idaho | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Kansas City | Kansas | United States |
| Research Site | Overland Park | Kansas | 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 | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Hamilton | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Albany | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Pahrump | 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 | Lubbock | 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 | Hämeenlinna | Finland |
| Research Site | Helsinki | Finland |
| Research Site | Joensuu | Finland |
| Research Site | Kouvola | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Mikkeli | Finland |
| Research Site | Oulu | Finland |
| Research Site | Salo | Finland |
| Research Site | Tampere | Finland |
| Research Site | Vantaa | Finland |
| Research Site | Aschaffenburg | Germany |
| Research Site | Bad Segeberg | Germany |
| Research Site | Beckum | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Ehrenberg | Germany |
| Research Site | Essen | Germany |
| Research Site | Feldafing | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hanover | Germany |
| Research Site | Hermaringen | Germany |
| Research Site | Künzing | Germany |
| Research Site | Langen | Germany |
| Research Site | Mannheim | Germany |
| Research Site | Marl | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Pirna | Germany |
| Research Site | Rotenburg/Fulda | Germany |
| 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 | Beek en Donk | Netherlands |
| Research Site | Bennebroe | 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 | Bergen | Norway |
| Research Site | Oslo | Norway |
| Research Site | Østerås | Norway |
| Research Site | San Vicente de Raspeig | Alicante | Spain |
| Research Site | Villar del Arzobispo | Valencia | Spain |
| Research Site | Alzira (Valencia) | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Begonte (Lugo) | Spain |
| Research Site | Madrid | Spain |
| Research Site | Seville | Spain |
| Research Site | Aberdeen | United Kingdom |
| Research Site | Ayr | United Kingdom |
| Research Site | Bath | United Kingdom |
| Research Site | Berks | United Kingdom |
| Research Site | Bucks | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Sites | Northampton | 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 |
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