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

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: metformin (Drug); sulphonylurea (Drug); Avandamet (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical trials, DM, FRCP, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary outcome:

Change in FPG (fasting plasma glucose)

insulin sensitivity

beta cell function

change in PAI-1

CRP

number of hypoglycaemic events

Change in 24 hr ABPM

Diabetes treatment satisfaction.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Brugge 8000, Belgium

GSK Clinical Trials Call Center, Lode 3120, Belgium

GSK Clinical Trials Call Center, Wilebroek 2830, Belgium

GSK Clinical Trials Call Center, Heverlee 3001, Belgium

GSK Clinical Trials Call Center, Oostham 3945, Belgium

GSK Clinical Trials Call Center, Namur (Champion) 5020, Belgium

GSK Clinical Trials Call Center, Petit-Rechain 4800, Belgium

GSK Clinical Trials Call Center, Zandhoven (Pulle) 2243, Belgium

GSK Clinical Trials Call Center, Bruxelles 1030, Belgium

GSK Clinical Trials Call Center, Landen 3400, Belgium

GSK Clinical Trials Call Center, Bruxelles 1210, Belgium

GSK Clinical Trials Call Center, Tessenderlo 3980, Belgium

GSK Clinical Trials Call Centre, Roubaix 59100, France

GSK Clinical Trials Call Centre, Anzin 59410, France

GSK Clinical Trials Call Centre, Saint Ouen 93400, France

GSK Clinical Trials Call Centre, Segre 49500, France

GSK Clinical Trials Call Centre, Venissieux 69200, France

GSK Clinical Trials Call Centre, Lyon 69007, France

GSK Clinical Trials Call Centre, Roanne 42300, France

GSK Clinical Trials Call Centre, Louverne 53950, France

GSK Clinical Trials Call Centre, Laval 53000, France

GSK Clinical Trials Call Centre, Commelle Vernay 42120, France

GSK Clinical Trials Call Centre, Sainte Suzanne 53270, France

GSK Clinical Trials Call Centre, Evron 53600, France

GSK Clinical Trials Call Centre, Paris 75015, France

GSK Clinical Trials Call Centre, Cremeaux 42260, France

GSK Clinical Trials Call Centre, Briollay 49125, France

GSK Clinical Trials Call Centre, Elmshorn 25335, Germany

GSK Clinical Trials Call Centre, Dublin 24, Ireland

GSK Clinical Trials Call Centre, Dublin 8, Ireland

GSK Clinical Trials Call Centre, Dublin 9, Ireland

GSK Clinical Trials Call Centre, Blanchardstown 15, Ireland

GSK Clinical Trials Call Centre, Sassari 7100, Italy

GSK Clinical Trials Call Centre, Mostoles/ Madrid 28935, Korea, Republic of

GSK Clinical Trials Call Centre, Vilnius LT-07156, Lithuania

GSK Clinical Trials Call Centre, Kaunas LT-44320, Lithuania

GSK Clinical Trials Call Centre, Kaunas LT-49335, Lithuania

GSK Clinical Trials Call Centre, Vilnius LT-08661, Lithuania

GSK Clinical Trials Call Center, Tijuana 22320, Mexico

GSK Clinical Trials Call Center, Pachuca 42039, Mexico

GSK Clinical Trials Call Center, Durango 3400, Mexico

GSK Clinical Trials Call Center, Guadalajara 44340, Mexico

GSK Clinical Trials Call Center, Mexico, D.F 11850, Mexico

GSK Clinical Trials Call Centre, Beerzerveld 7685 PG, Netherlands

GSK Clinical Trials Call Centre, Zieuwent 7136 KH, Netherlands

GSK Clinical Trials Call Centre, Woerden 3443 GG, Netherlands

GSK Clinical Trials Call Centre, Heerlen 6416 EG, Netherlands

GSK Clinical Trials Call Centre, Den Haag 2584 HV, Netherlands

GSK Clinical Trials Call Centre, Hoogvliet 3192 JN, Netherlands

GSK Clinical Trials Call Centre, Musselkanaal 9581 AJ, Netherlands

GSK Clinical Trials Call Centre, Oude Pekela 9665 AR, Netherlands

GSK Clinical Trials Call Centre, Spijkenisse 3207 NB, Netherlands

GSK Clinical Trials Call Center, DEN HAAG 2582 LJ, Netherlands

GSK Clinical Trials Call Center, Beek En Donk 5741 CG, Netherlands

GSK Clinical Trials Call Centre, Zaandam 1504 JA, Netherlands

GSK Clinical Trials Call Centre, Landgraaf 6373 JS, Netherlands

GSK Clinical Trials Call Centre, Alcobendas/Madrid 28100, Spain

GSK Clinical Trials Call Centre, Gerona, Spain

GSK Clinical Trials Call Centre, Madrid 28046, Spain

GSK Clinical Trials Call Centre, Malaga 29009, Spain

GSK Clinical Trials Call Centre, Artana/Castellon 12527, Spain

GSK Clinical Trials Call Centre, Sabadell (Barcelona) 8208, Spain

GSK Clinical Trials Call Centre, Alcora/Castellon 12110, Spain

GSK Clinical Trials Call Centre, Tarrasa (Barcelona) 8221, Spain

GSK Clinical Trials Call Centre, Madrid 28041, Spain

GSK Clinical Trials Call Centre, Onda (Castellon), Spain

GSK Clinical Trials Call Centre, Benicassim, Spain

GSK Clinical Trials Call Centre, Castellon, Spain

GSK Clinical Trials Call Centre, San Juan De Alicante 3550, Spain

GSK Clinical Trials Call Centre, Granada 18014, Spain

GSK Clinical Trials Call Centre, Merida 6800, Spain

GSK Clinical Trials Call Centre, Pontevedra 36002, Spain

GSK Clinical Trials Call Center, Caceres 10004, Spain

GSK Clinical Trials Call Centre, Madrid 28034, Spain

GSK Clinical Trials Call Centre, Valencia 46010, Spain

GSK Clinical Trials Call Centre, Alzira 46600, Spain

GSK Clinical Trials Call Centre, Alicante, Spain

GSK Clinical Trials Call Centre, Barcelona 8015, Spain

GSK Clinical Trials Call Centre, Barcelona 8022, Spain

GSK Clinical Trials Call Centre, Benesal (Valencia), Spain

GSK Clinical Trials Call Centre, Madrid 28037, Spain

GSK Clinical Trials Call Centre, Barcelona 8923, Spain

GSK Clinical Trials Call Centre, Cadiz 11009, Spain

GSK Clinical Trials Call Centre, Steckborn 8266, Switzerland

GSK Clinical Trials Call Centre, Salmsach 8599, Switzerland

GSK Clinical Trials Call Centre, Lugano 6900, Switzerland

GSK Clinical Trials Call Centre, Emmenbrucke 6020, Switzerland

GSK Clinical Trials Call Centre, Zurich 8046, Switzerland

GSK Clinical Trials Call Centre, Jegenstorf 3303, Switzerland

GSK Clinical Trials Call Centre, St Maurice 1890, Switzerland

GSK Clinical Trials Call Centre, Gettnau 6142, Switzerland

GSK Clinical Trials Call Centre, Zurich 8050, Switzerland

GSK Clinical Trials Call Centre, Winterthur 8405, Switzerland

GSK Clinical Trials Call Centre, Winterthur 8400, Switzerland

GSK Clinical Trials Call Centre, Bern 3007, Switzerland

GSK Clinical Trials Call Centre, Luzern 6004, Switzerland

GSK Clinical Trials Call Centre, Sheffield S5 7AU, United Kingdom

GSK Clinical Trials Call Centre, Bristol BS2 8HW, United Kingdom

GSK Clinical Trials Call Centre, Leeds LS12 1JE, United Kingdom

GSK Clinical Trials Call Centre, Bath BA1 3NG, United Kingdom

GSK Clinical Trials Call Centre, Glasgow G3 8YJ, United Kingdom

GSK Clinical Trials Call Centre, Glasgow G69 7AD, United Kingdom

GSK Clinical Trials Call Centre, Kippenheim, Baden-Wurttemberg 77971, Germany

GSK Clinical Trials Call Centre, Waldshut-Tiengen, Baden-Wurttemberg 79961, Germany

GSK Clinical Trials Call Centre, Gueglingen, Baden-Wurttemberg 74363, Germany

GSK Clinical Trials Call Centre, Koenigsfeld, Baden-Wurttemberg 78126, Germany

GSK Clinical Trials Call Centre, Weinheim, Baden-Wurttemberg 68469, Germany

GSK Clinical Trials Call Centre, Herzogenaurach, Bayern 91074, France

GSK Clinical Trials Call Centre, Oberteisendorf, Bayern 83317, Germany

GSK Clinical Trials Call Centre, Immenstadt, Bayern 87509, Germany

GSK Clinical Trials Call Centre, Saaldorf-Surheim, Bayern 83416, Germany

GSK Clinical Trials Call Centre, Wuerzburg, Bayern 97072, Germany

GSK Clinical Trials Call Centre, Grafing, Bayern 85567, Germany

GSK Clinical Trials Call Centre, Wallerfing, Bayern 94574, Germany

GSK Clinical Trials Call Centre, Nuernberg, Bayern 90402, Germany

GSK Clinical Trials Call Centre, Bologna, Emilia Romagna 40138, Italy

GSK Clinical Trials Call Centre, Ferrara, Emilia Romagna 44100, Italy

GSK Clinical Trials Call Centre, Ravenna, Emilia Romagna 48100, Italy

GSK Clinical Trials Call Centre, Grissalmerode, Hessen 37247, Germany

GSK Clinical Trials Call Centre, Blackpool, Lancashire FY4 3AD, United Kingdom

GSK Clinical Trials Call Centre, Genova, Liguria 16132, Italy

GSK Clinical Trials Call Centre, Arenzano, Liguria 16011, Italy

GSK Clinical Trials Call Centre, Papenburg, Niedersachsen 26871, Germany

GSK Clinical Trials Call Centre, Einbeck, Niedersachsen 37574, Germany

GSK Clinical Trials Call Centre, Isernhagen, Niedersachsen 30916, Germany

GSK Clinical Trials Call Centre, Hannover, Niedersachsen 30519, Germany

GSK Clinical Trials Call Centre, Beckum, Nordrhein-Westfalen 59269, Germany

GSK Clinical Trials Call Centre, Bergkamen-Runthe, Nordrhein-Westfalen 59192, Germany

GSK Clinical Trials Call Centre, Dortmund, Nordrhein-Westfalen 44137, Germany

GSK Clinical Trials Call Centre, Bochum, Nordrhein-Westfalen 44869, Germany

GSK Clinical Trials Call Centre, Goch, Nordrhein-Westfalen 47574, Germany

GSK Clinical Trials Call Centre, Dinslaken, Nordrhein-Westfalen 46537, Germany

GSK Clinical Trials Call Centre, Koeln, Nordrhein-Westfalen 51069, Germany

GSK Clinical Trials Call Centre, Essen, Nordrhein-Westfalen 45134, Germany

GSK Clinical Trials Call Centre, Essen, Nordrhein-Westfalen 45359, Germany

GSK Clinical Trials Call Centre, Viersen, Nordrhein-Westfalen 41749, Germany

GSK Clinical Trials Call Centre, Rhaunen, Rheinland-Pfailz 55624, Germany

GSK Clinical Trials Call Centre, Speyer, Rheinland-Pfailz 67346, Germany

GSK Clinical Trials Call Centre, Neuwied, Rheinland-Pfailz 56564, Germany

GSK Clinical Trials Call Centre, Mainz, Rheinland-Pfailz 55116, Germany

GSK Clinical Trials Call Centre, Saarlouis, Saarland 66740, Germany

GSK Clinical Trials Call Centre, Dresden, Sachsen 1219, Germany

GSK Clinical Trials Call Centre, Wolmirstedt, Sachsen-Anhalt 39326, Germany

GSK Clinical Trials Call Centre, Perugia, Umbria 6126, Italy

GSK Clinical Trials Call Centre, Citta di Castello, Umbria 6012, Italy

GSK Clinical Trials Call Centre, Terni, Umbria 5100, Italy

Starting date: May 2004
Last updated: July 31, 2006