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Clinical Trial Details

Trial ID: L3092
Source ID: NCT00214565
Associated Drug: Galida
Title: GALLANT 6 Tesaglitazar vs. Pioglitazone
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Galida
Outcome Measures: Primary: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | Secondary: 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|Lipid parameters|FPG, homeostasis assessment model, insulin, proinsulin, C-peptide|Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values|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|Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)|Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1450
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-08
Completion Date: 2006-10
Results First Posted:
Last Update Posted: 2010-11-19
Locations: Research Site, Altoona, Pennsylvania, United States|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Córdoba, Argentina|Research Site, Moron- Buenos Aires, Argentina|Research Sites, Quilmes - Buenos Aires, Argentina|Research Site, Rosario, Argentina|Research Site, Salta, Argentina|Research Site, Curitiba, Brazil|Research Site, Edmonton, Alberta, Canada|Research Site, Abbotsford, British Columbia, Canada|Research Site, Chilliwack, British Columbia, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, Victoria, British Columbia, 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, Ontario, Canada|Research Site, St. Catharines, Ontario, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Windsor, Ontario, Canada|Research Site, Trois-Rivières, Quebec, Canada|Research Site, Chicoutimi, Canada|Research Site, Longueuil, Canada|Research Site, Montreal, Canada|Research Site, St. John's, Canada|Research Site, Espoo, Finland|Research Site, Helsinki, Finland|Research Site, Kuopio, Finland|Research Site, Pietarsaar, Finland|Research Site, Pori, Finland|Research Site, Tampere, Finland|Research Site, Guadalajara Jalisco, Mexico|Research Site, Mexico City, Mexico|Research Site, Mexico, Mexico|Research Site, Nuevo Leon, Mexico|Research Site, Puebla, Mexico|Research Site, Torreon, Mexico|Research Site, Zapopan, Mexico|Research Site, Bergen, Norway|Research Site, Elvernum, Norway|Research Site, Hamar, Norway|Research Site, Horten, Norway|Research Site, Kongsberg, Norway|Research Site, Lena, Norway|Research Site, Loeten, Norway|Research Site, Lysaker, Norway|Research Site, Oslo, Norway|Research Site, Osteraas, Norway|Research Site, Skedsmokorset, Norway|Research Site, Straume, Norway|Research Site, Toensberg, Norway|Research Site, Tronheim, Norway|Research Site, Ås, Norway|Research Site, Dublin, Ireland, United Kingdom|Research Site, Wexford, Ireland, United Kingdom|Research Site, Antrim, NI, United Kingdom|Research Site, Belfast, United Kingdom|Research Site, Cardiff, 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
URL: https://clinicaltrials.gov/show/NCT00214565

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