AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

NCT ID: NCT00359112

Last Updated: 2009-05-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Brief Summary

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This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

Detailed Description

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Conditions

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Non-Insulin-Dependent Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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metformin

Intervention Type DRUG

sulphonylurea

Intervention Type DRUG

Avandamet

Intervention Type DRUG

Other Intervention Names

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metformin sulphonylurea

Eligibility Criteria

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Inclusion Criteria

* Body mass index \> or = to 25 kg/m2.
* 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

* Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

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

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Brussels, , Belgium

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Brussels, , Belgium

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Champion, , Belgium

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Heverlee, , Belgium

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Landen, , Belgium

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Oostham, , Belgium

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Petit-Rechain, , Belgium

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Pulle, , Belgium

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Tessenderlo, , Belgium

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Tremelo, , Belgium

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Willebroek, , Belgium

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Roubaix, Hauts-de-France, France

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Anzin, , France

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Briollay, , France

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Commelle, , France

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Cremeaux, , France

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Évron, , France

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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

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Güglingen, Baden-Wurttemberg, Germany

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Kippenheim, Baden-Wurttemberg, Germany

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Königsfeld im Schwarzwald, Baden-Wurttemberg, Germany

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Waldshut-Tiengen, Baden-Wurttemberg, Germany

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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

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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

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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

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Sheffield, , United Kingdom

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Countries

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Belgium France Germany Ireland Italy Lithuania Mexico Netherlands Spain Switzerland United Kingdom

Other Identifiers

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AVM100264

Identifier Type: -

Identifier Source: org_study_id

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