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Clinical Trial Details

Trial ID: L5666
Source ID: NCT00252837
Associated Drug: Tesaglitazar
Title: GALLANT 22 Tesaglitazar vs. Placebo
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Tesaglitazar|BEHAVIORAL: Dietary and Lifestyle counseling
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:|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|Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide|Tumor necrosis factor-alpha, intracellular adhesion molecule-1|Fibrinogen|Proportion of patients with microalbuminuria|Waist/hip ratio|Responder analyses for HbA1c, FPG, TG, HDL C, 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|Patient-reported outcomes: Well-Being Questionnaire (W BQ12)|Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 475
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2005-04
Completion Date: 2006-12
Results First Posted:
Last Update Posted: 2008-03-17
Locations: Research Site, Adelaide, Australia|Research Site, Cairns, Australia|Research Site, Gosford, Australia|Research Site, Keswick, Australia|Research Site, Kippa Ring, Australia|Research Site, Melbourne, Australia|Research Site, Miranda, Australia|Research Site, Nowra, Australia|Research Site, Wollongong, Australia|Research Site, Brno, Czech Republic|Research Site, Hodonin, Czech Republic|Research Site, Hradec Kralove, Czech Republic|Research Site, Plzen, Czech Republic|Research Site, Praha 5, Czech Republic|Research Site, Pribram, Czech Republic|Research Site, Semily, Czech Republic|Research Site, Tabor, Czech Republic|Research Site, Usti nad Labem, Czech Republic|Research Site, Paide, Estonia|Research Site, Pärnu, Estonia|Research Site, Tallinn, Estonia|Research Site, Tartu, Estonia|Research Site, Viljandi, Estonia|Research Site, Belgrade, Former Serbia and Montenegro|Research Site, Angers, France|Research Site, Briollay, France|Research Site, Poitiers, France|Research Site, Saint Benoit, France|Research Site, Saint Ouen, France|Research Site, Toulouse, France|Research Site, Trelaze, France|Research Site, Athens, Greece|Research Site, Piraeus, Greece|Research Site, Balatonfüred, Hungary|Research Site, Budapest, Hungary|Research Site, Kaposvár, Hungary|Research Site, Kecskemét, Hungary|Research Site, Székesfehérvár, Hungary|Research Site, Daugavpils, Latvia|Research Site, Jekabpils, Latvia|Research Site, Madona, Latvia|Research Site, Riga, Latvia|Research Site, SIgulda, Latvia|Research Site, Talsi, Latvia|Research Site, Valmiera, Latvia|Research Site, Kaunas, Lithuania|Research Site, Klaipeda, Lithuania|Research Site, Panevezys, Lithuania|Research Site, Vilnius, Lithuania|Research Site, Aurskog, Norway|Research Site, Bergen, Norway|Research Site, Enebakk, Norway|Research Site, Fredrikstad, Norway|Research Site, Haugesund, Norway|Research Site, Hønefoss, Norway|Research Site, Inderøy, Norway|Research Site, Larvik, Norway|Research Site, Lierskogen, Norway|Research Site, Oslo, Norway|Research Site, Rolvsøy, Norway|Research Site, Cebu City, Philippines|Research Site, Pasig City, 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, Lublin, Poland|Research Site, Olsztyn, Poland|Research Site, Poznań, Poland|Research Site, Radom, Poland|Research Site, Rzeszow, Poland|Research Site, Sopot, Poland|Research Site, Szczecin, Poland|Research Site, Toruñ, Poland|Research Site, Tychy, Poland|Research Site, Warszawa, Poland|Research Site, Wroclaw, Poland|Research Site, Zabrze, Poland|Research Site, Zielona Gora, Poland|Research Site, Dolny Kubin, Slovakia|Research Site, Levice, Slovakia|Research Site, Lubochna, Slovakia|Research Site, Lucenec, Slovakia|Research Site, Nove Zamky, Slovakia|Research Site, Povazska Bystrica, Slovakia|Research Site, Sahy, Slovakia|Research Site, Trencin, Slovakia|Research Site, Velky Meder, Slovakia|Research Site, Zilina, Slovakia|Research Site, Borås, Sweden|Research Site, Göteborg, Sweden|Research Site, Mölndal, Sweden|Research Site, Partille, Sweden|Research Site, Skene, Sweden|Research Site, Stenungsund, Sweden|Research Site, Uddevalla, Sweden|Research Site, Vänersborg, Sweden|Research Site, Åmål, Sweden
URL: https://clinicaltrials.gov/show/NCT00252837

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress