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Clinical Trial Details

Trial ID: L7310
Source ID: NCT00251953
Associated Drug: Tesaglitazar
Title: GALLANT 8 Tesaglitazar Add-on to Metformin
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Tesaglitazar|DRUG: Metformin
Outcome Measures: Primary: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | Secondary: Changes in the following variables from baseline to the end of the randomized treatment period:|Fasting plasma glucose (FPG), insulin, proinsulin and C-peptide|Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model|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 c|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
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 555
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-07
Completion Date: 2006-03
Results First Posted:
Last Update Posted: 2009-04-22
Locations: 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, Coquitlam, British Columbia, Canada|Research Site, Winnipeg, Manitoba, Canada|Research Site, St. John's, Newfoundland and Labrador, Canada|Research Site, Etobicoke, Ontario, Canada|Research Site, Hamilton, Ontario, Canada|Research Site, Hastings, Ontario, Canada|Research Site, Kingston, 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, Montréal, Quebec, Canada|Research Site, Helsinki, Finland|Research Site, Hämeenlinna, 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, Berlin, Germany|Research Site, Essen, Germany|Research Site, Hamburg, Germany|Research Site, Heidelberg, Germany|Research Site, Mannheim, Germany|Research Site, Nürberg, Germany|Research Site, Rotenburg/Fulda, Germany|Research Site, Bangalore, India|Research Site, Hyderabad, India|Research Site, New Delhi, India|Research Site, Arenzano, Italy|Research Site, Chiavari (GE), Italy|Research Site, Chieri, Italy|Research Site, Desio, Italy|Research Site, Firenze, Italy|Research Site, Gubbio, Italy|Research Site, Marsala, Italy|Research Site, Messina, Italy|Research Site, Milano, Italy|Research Site, Monteccio Emilia, Italy|Research Site, Napoli, Italy|Research Site, Padova, Italy|Research Site, Perugia, 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, Rho, Italy|Research Site, Roma, Italy|Research Site, Scandiano, Italy|Research Site, Udine, Italy|Research Site, Kubang Kerian, Kota Bharu, Malaysia|Research Site, Kuala Lumpur, Malaysia|Research Site, Cebu City, Philippines|Research Site, Quezon City, Philippines|Research Site, Singapore, Singapore|Research Site, Borås, Sweden|Research Site, Dalby, Sweden|Research Site, Göteborg, Sweden|Research Site, Höganäs, Sweden|Research Site, Kungsör, Sweden|Research Site, Malmö, Sweden|Research Site, Mölndal, Sweden|Research Site, Oskarshamn, Sweden|Research Site, Skene, Sweden|Research Site, Skrivarp, Sweden|Research Site, Stenungsund, Sweden|Research Site, Uppsala, Sweden|Research Site, Ängelholm, Sweden|Research Site, Aberdeen, United Kingdom|Research Site, Aldershot, United Kingdom|Research Site, Atherstone, United Kingdom|Research Site, Barry, United Kingdom|Research Site, Bath, United Kingdom|Research Site, Bexhill-on-Sea, United Kingdom|Research Site, Birmingham, United Kingdom|Research Site, Bolton, United Kingdom|Research Site, Cardiff, United Kingdom|Research Site, Chippenham, United Kingdom|Research Site, Coventry, United Kingdom|Research Site, Dundee, United Kingdom|Research Site, Edinburgh, United Kingdom|Research Site, Glasgow, United Kingdom|Research Site, Harrow, United Kingdom|Research Site, Hastings, United Kingdom|Research Site, Leeds, United Kingdom|Research Site, Liverpool, United Kingdom|Research Site, Manchester, United Kingdom|Research Site, Plymouth, United Kingdom|Research Site, Radstock, United Kingdom|Research Site, Slough, United Kingdom|Research Site, Swindon, United Kingdom|Research Site, West Midlands, United Kingdom|Research Site, Wrexham, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00251953

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details