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

NCT00359112 | Completed Phase 3

• 1 other identifier: AVM100264
• Study Type: interventional
• Target: 544
• Locations: 11 countries
• Sites: 142

Brief Summary

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

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Keywords

Type 2 diabetes; overweight; AVANDAMET; metformin; sulphonylurea

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary Outcomes (8)

• Change in FPG (fasting plasma glucose)

• insulin sensitivity

• beta cell function

• change in PAI-1

• CRP

Interventions

metformin DRUG

sulphonylurea DRUG

Avandamet DRUG

Also known as: metformin, sulphonylurea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (142)

GSK Investigational Site

Bruges, 8000, Belgium

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GSK Investigational Site

Brussels, 1030, Belgium

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GSK Investigational Site

Brussels, 1210, Belgium

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GSK Investigational Site

Champion, 5020, Belgium

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GSK Investigational Site

Heverlee, 3001, Belgium

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GSK Investigational Site

Landen, 3400, Belgium

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GSK Investigational Site

Oostham, 3945, Belgium

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GSK Investigational Site

Petit-Rechain, 4800, Belgium

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GSK Investigational Site

Pulle, 2243, Belgium

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GSK Investigational Site

Tessenderlo, 3980, Belgium

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GSK Investigational Site

Tremelo, 3120, Belgium

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GSK Investigational Site

Willebroek, 2830, Belgium

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GSK Investigational Site

Roubaix, Hauts-de-France, 59100, France

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GSK Investigational Site

Anzin, 59410, France

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GSK Investigational Site

Briollay, 49125, France

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GSK Investigational Site

Commelle, 42120, France

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GSK Investigational Site

Cremeaux, 42260, France

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GSK Investigational Site

Évron, 53600, France

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GSK Investigational Site

Laval, 53000, France

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GSK Investigational Site

Louverné, 53950, France

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GSK Investigational Site

Lyon, 69007, France

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Paris, 75015, France

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GSK Investigational Site

Roanne, 42300, France

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GSK Investigational Site

Saint-Ouen, 93400, France

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GSK Investigational Site

Sainte-Suzanne, 53270, France

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GSK Investigational Site

Segré, 49500, France

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GSK Investigational Site

Vénissieux, 69200, France

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GSK Investigational Site

Güglingen, Baden-Wurttemberg, 74363, Germany

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GSK Investigational Site

Kippenheim, Baden-Wurttemberg, 77971, Germany

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GSK Investigational Site

Königsfeld im Schwarzwald, Baden-Wurttemberg, 78126, Germany

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GSK Investigational Site

Waldshut-Tiengen, Baden-Wurttemberg, 79961, Germany

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Weinheim, Baden-Wurttemberg, 69469, Germany

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Grafing, Bavaria, 85567, Germany

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Herzogenaurach, Bavaria, 91074, Germany

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Immenstadt im Allgäu, Bavaria, 87509, Germany

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Oberteisendorf, Bavaria, 83317, Germany

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Saaldorf, Bavaria, 83416, Germany

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Wallerfing, Bavaria, 94574, Germany

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Würzburg, Bavaria, 97072, Germany

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Großalmerode, Hesse, 37247, Germany

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Einbeck, Lower Saxony, 37574, Germany

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Hanover, Lower Saxony, 30519, Germany

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Isernhagen-Süd, Lower Saxony, 30916, Germany

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Papenburg, Lower Saxony, 26871, Germany

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Beckum, North Rhine-Westphalia, 59269, Germany

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Bergkamen-Rünthe, North Rhine-Westphalia, 59192, Germany

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Bochum, North Rhine-Westphalia, 44869, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Dinslaken, North Rhine-Westphalia, 46537, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Essen, North Rhine-Westphalia, 45134, Germany

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Essen, North Rhine-Westphalia, 45359, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Viersen, North Rhine-Westphalia, 41749, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

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GSK Investigational Site

Neuwied, Rhineland-Palatinate, 56564, Germany

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GSK Investigational Site

Rhaunen, Rhineland-Palatinate, 55624, Germany

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GSK Investigational Site

Speyer, Rhineland-Palatinate, 67346, Germany

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GSK Investigational Site

Saarlouis, Saarland, 66740, Germany

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GSK Investigational Site

Dresden, Saxony, 01219, Germany

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Wolmirstedt, Saxony-Anhalt, 39326, Germany

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Elmshorn, Schleswig-Holstein, 25335, Germany

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GSK Investigational Site

Blanchardstown, 15, Ireland

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Dublin, 8, Ireland

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GSK Investigational Site

Dublin, 9, Ireland

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Bologna, Emilia-Romagna, 40138, Italy

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Ferrara, Emilia-Romagna, 44100, Italy

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Ravenna, Emilia-Romagna, 48100, Italy

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GSK Investigational Site

Arenzano (GE), Liguria, 16011, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Sassari, Sardinia, 07100, Italy

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Città Di Castello (PG), Umbria, 06012, Italy

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GSK Investigational Site

Terni, Umbria, 05100, Italy

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GSK Investigational Site

Kaunas, LT-44320, Lithuania

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GSK Investigational Site

Kaunas, LT-49335, Lithuania

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GSK Investigational Site

Vilnius, LT-07156, Lithuania

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GSK Investigational Site

Vilnius, LT-08661, Lithuania

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GSK Investigational Site

Tijuana, Baja California Norte, 22320, Mexico

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Durango, Durango, 3400, Mexico

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Pachuca, Hidalgo, 42039, Mexico

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Guadalajara, Jalisco, 44340, Mexico

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GSK Investigational Site

Mexico City, 11850, Mexico

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GSK Investigational Site

Beek en Donk, 5741 CG, Netherlands

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GSK Investigational Site

Beerzerveld, 7685 PG, Netherlands

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GSK Investigational Site

Heerlen, 6416 EG, Netherlands

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GSK Investigational Site

Hoogvliet, 3192 JN, Netherlands

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Landgraaf, 6373 JS, Netherlands

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GSK Investigational Site

Musselkanaal, 9581 AJ, Netherlands

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GSK Investigational Site

Oude Pekela, 9665 AR, Netherlands

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GSK Investigational Site

Spijkenisse, 3207 NB, Netherlands

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The Hague, 2582 LJ, Netherlands

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GSK Investigational Site

Woerden, 3443 GG, Netherlands

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GSK Investigational Site

Zaandam, 1504 JA, Netherlands

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GSK Investigational Site

Zieuwent, 7136 KH, Netherlands

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Alcobendas/Madrid, 28100, Spain

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Alcora/Castellón, 12110, Spain

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Alicante, Spain

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Alzira, 46600, Spain

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GSK Investigational Site

Artana/Castellón, 12527, Spain

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GSK Investigational Site

Barcelona, 08015, Spain

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GSK Investigational Site

Barcelona, 08022, Spain

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GSK Investigational Site

Benicassim (Castellon), Spain

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GSK Investigational Site

Cadiz, 11009, Spain

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Castellon, Spain

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GSK Investigational Site

Cáceres, 10004, Spain

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Girona, Spain

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GSK Investigational Site

Granada, 18014, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28037, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Málaga, 29009, Spain

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GSK Investigational Site

Mérida, 6800, Spain

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GSK Investigational Site

Móstoles/Madrid, 28935, Spain

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GSK Investigational Site

Onda (Castellon), Spain

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GSK Investigational Site

Pontevedra, 36002, Spain

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GSK Investigational Site

Sabadell (Barcelona), 08208, Spain

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GSK Investigational Site

Sant Joan d'Alacant, 3550, Spain

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GSK Investigational Site

Santa Coloma de Gramanet (Barcelona), 08923, Spain

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GSK Investigational Site

Tarrasa, Barcelona, 08221, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Bern, 3007, Switzerland

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GSK Investigational Site

Emmenbrücke, 6020, Switzerland

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GSK Investigational Site

Gettnau, 6142, Switzerland

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GSK Investigational Site

Jegenstorf, 3303, Switzerland

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GSK Investigational Site

Lucerne, 6004, Switzerland

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GSK Investigational Site

Lugano, 6900, Switzerland

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GSK Investigational Site

Pregassona, 6963, Switzerland

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GSK Investigational Site

Salmsach, 8599, Switzerland

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GSK Investigational Site

St-Maurice, 1890, Switzerland

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GSK Investigational Site

Steckborn, 8266, Switzerland

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Winterthur, 8400, Switzerland

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GSK Investigational Site

Winterthur, 8405, Switzerland

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GSK Investigational Site

Zurich, 8046, Switzerland

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GSK Investigational Site

Zurich, 8050, Switzerland

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GSK Investigational Site

Glasgow, Lanarkshire, G3 8YJ, United Kingdom

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GSK Investigational Site

Glasgow, Lanarkshire, G69 7AD, United Kingdom

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GSK Investigational Site

Blackpool, Lancashire, FY4 3AD, United Kingdom

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GSK Investigational Site

Bath, Somerset, BA1 3NG, United Kingdom

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GSK Investigational Site

Bristol, BS2 8HW, United Kingdom

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GSK Investigational Site

Leeds, LS12 1JE, United Kingdom

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GSK Investigational Site

Sheffield, S5 7AU, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Interventions

Metformin; Sulfonylurea Compounds; rosiglitazone-metformin combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds

Study Officials

• GSK Clinical Trials, DM, FRCP

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: February 1, 2004
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

ES (27); BE (12); IT (8); NL (12); IE (3); LI (4); ME (5); GB (7); DE (35); FR (15); CH (14)