AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
NCT ID: NCT00359112
Last Updated: 2009-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
544 participants
INTERVENTIONAL
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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metformin
sulphonylurea
Avandamet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c \> or =7% and \< or =10% at screening.
* FPG \> or = 7.0mmol/L (126mg/dL) at visit 2.
* Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
* Female subjects must be postmenopausal or using effective contraceptive measures.
Exclusion Criteria
* Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
* Subjects with a history of severe hypoglycaemia.
* Renal disease or renal dysfunction.
* Presence of clinically significant hepatic disease.
* Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
* Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials, DM, FRCP
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Bruges, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Champion, , Belgium
GSK Investigational Site
Heverlee, , Belgium
GSK Investigational Site
Landen, , Belgium
GSK Investigational Site
Oostham, , Belgium
GSK Investigational Site
Petit-Rechain, , Belgium
GSK Investigational Site
Pulle, , Belgium
GSK Investigational Site
Tessenderlo, , Belgium
GSK Investigational Site
Tremelo, , Belgium
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Willebroek, , Belgium
GSK Investigational Site
Roubaix, Hauts-de-France, France
GSK Investigational Site
Anzin, , France
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Briollay, , France
GSK Investigational Site
Commelle, , France
GSK Investigational Site
Cremeaux, , France
GSK Investigational Site
Évron, , France
GSK Investigational Site
Laval, , France
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Louverné, , France
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Lyon, , France
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Paris, , France
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Roanne, , France
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Saint-Ouen, , France
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Sainte-Suzanne, , France
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Segré, , France
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Vénissieux, , France
GSK Investigational Site
Güglingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Kippenheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Königsfeld im Schwarzwald, Baden-Wurttemberg, Germany
GSK Investigational Site
Waldshut-Tiengen, Baden-Wurttemberg, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, Germany
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Grafing, Bavaria, Germany
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Herzogenaurach, Bavaria, Germany
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Immenstadt im Allgäu, Bavaria, Germany
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Oberteisendorf, Bavaria, Germany
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Saaldorf, Bavaria, Germany
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Wallerfing, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Großalmerode, Hesse, Germany
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Einbeck, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Isernhagen-Süd, Lower Saxony, Germany
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Papenburg, Lower Saxony, Germany
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Beckum, North Rhine-Westphalia, Germany
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Bergkamen-Rünthe, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dinslaken, North Rhine-Westphalia, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Viersen, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Neuwied, Rhineland-Palatinate, Germany
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Rhaunen, Rhineland-Palatinate, Germany
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Speyer, Rhineland-Palatinate, Germany
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Saarlouis, Saarland, Germany
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Dresden, Saxony, Germany
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Wolmirstedt, Saxony-Anhalt, Germany
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Elmshorn, Schleswig-Holstein, Germany
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Blanchardstown, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Bologna, Emilia-Romagna, Italy
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Ferrara, Emilia-Romagna, Italy
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Ravenna, Emilia-Romagna, Italy
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Arenzano (GE), Liguria, Italy
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Genoa, Liguria, Italy
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Sassari, Sardinia, Italy
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Città Di Castello (PG), Umbria, Italy
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Terni, Umbria, Italy
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Tijuana, Baja California Norte, Mexico
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Durango, Durango, Mexico
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Pachuca, Hidalgo, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, , Mexico
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Beek en Donk, , Netherlands
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Beerzerveld, , Netherlands
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Heerlen, , Netherlands
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Hoogvliet, , Netherlands
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Landgraaf, , Netherlands
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Musselkanaal, , Netherlands
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Oude Pekela, , Netherlands
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Spijkenisse, , Netherlands
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The Hague, , Netherlands
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Woerden, , Netherlands
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Zaandam, , Netherlands
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Zieuwent, , Netherlands
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Alcobendas/Madrid, , Spain
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Alcora/Castellón, , Spain
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Alicante, , Spain
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Alzira, , Spain
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Artana/Castellón, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Benicassim (Castellon), , Spain
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Cadiz, , Spain
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Castellon, , Spain
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Cáceres, , Spain
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Girona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
GSK Investigational Site
Málaga, , Spain
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Mérida, , Spain
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Móstoles/Madrid, , Spain
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Onda (Castellon), , Spain
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Pontevedra, , Spain
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Sabadell (Barcelona), , Spain
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Sant Joan d'Alacant, , Spain
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Santa Coloma de Gramanet (Barcelona), , Spain
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Tarrasa, Barcelona, , Spain
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Valencia, , Spain
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Bern, , Switzerland
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Emmenbrücke, , Switzerland
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Gettnau, , Switzerland
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Jegenstorf, , Switzerland
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Lucerne, , Switzerland
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Lugano, , Switzerland
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Pregassona, , Switzerland
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Salmsach, , Switzerland
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St-Maurice, , Switzerland
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Steckborn, , Switzerland
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Winterthur, , Switzerland
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Bath, Somerset, United Kingdom
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Bristol, , United Kingdom
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Leeds, , United Kingdom
GSK Investigational Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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AVM100264
Identifier Type: -
Identifier Source: org_study_id
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