Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients

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

Intervention: Rosiglitazone/metformin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

Official title: A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET* (8.0 mg / 2.0 g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

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

Primary outcome: Change from baseline in HbA1c

Secondary outcome: Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have been diagnosed with type II diabetes mellitus and not have adequate

glycaemic controlled while receiving at least 1. 5g of metformin.

- Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from

ankle swelling.

Exclusion Criteria:

- Patients cannot have any form of congestive heart failure or severe or unstable

angina.

- Patients cannot be currently receiving insulin, but be prepared to begin insulin

treatment.

GSK Clinical Trials Call Centre, Vienna 1100, Austria

GSK Clinical Trials Call Centre, Vienna 1030, Austria

GSK Clinical Trials Call Centre, Vienna 1060, Austria

Study Site - 001773, Rennes 35000, France

GSK Clinical Trials Call Centre, Lorient 56322, France

GSK Clinical Trials Call Centre, Venissieux 69200, France

GSK Clinical Trials Call Centre, Gotha 99867, Germany

GSK Clinical Trials Call Centre, Rhaunen 55624, Germany

GSK Clinical Trials Call Centre, Halberstadt 38820, Germany

GSK Clinical Trials Call Centre, Simmern 55469, Germany

GSK Clinical Trials Call Centre, Berlin 10789, Germany

GSK Clinical Trials Call Centre, Berlin 12351, Germany

GSK Clinical Trials Call Centre, Berlin 12347, Germany

GSK Clinical Trials Call Centre, Berlin 13057, Germany

GSK Clinical Trials Call Centre, Hamburg 20146, Germany

GSK Clinical Trials Call Centre, Hamburg 22041, Germany

GSK Clinical Trials Call Centre, Hamburg 22607, Germany

GSK Clinical Trials Call Centre, Pontevedra 36200, Spain

GSK Clinical Trials Call Centre, Barcelona 08022, Spain

GSK Clinical Trials Call Centre, Barcelona 08036, Spain

GSK Clinical Trials Call Centre, Madrid 28006, Spain

GSK Clinical Trials Call Centre, Madrid 28034, Spain

GSK Clinical Trials Call Centre, Madrid 28046, Spain

GSK Clinical Trials Call Centre, Madrid 28040, Spain

GSK Clinical Trials Call Centre, Pontevedra 26071, Spain

GSK Clinical Trials Call Centre, Valencia 46010, Spain

GSK Clinical Trials Call Centre, Bath BA1 2NG, United Kingdom

GSK Clinical Trials Call Centre, Dundee, Aberdeenshire DD1 9SY, United Kingdom

GSK Clinical Trials Call Centre, San Juan, Alicante 03550, Spain

GSK Clinical Trials Call Centre, San Vicente del Raspeig, Alicante 03690, Spain

GSK Clinical Trials Call Centre, Granada, Andalucia 18014, Spain

GSK Clinical Trials Call Centre, Cadiz, Andalucia 11009, Spain

GSK Clinical Trials Call Centre, ANGERS, Anjou 49000, France

GSK Clinical Trials Call Centre, Ilvesheim, Baden-Wurttemberg 68549, Germany

GSK Clinical Trials Call Centre, Sinsheim, Baden-Wurttemberg 74889, Germany

GSK Clinical Trials Call Centre, Hermaringen, Baden-Wurttemberg 89568, Germany

GSK Clinical Trials Call Centre, Lahr, Baden-Wurttemberg 77933, Germany

GSK Clinical Trials Call Centre, Mannheim, Baden-Wurttemberg 68199, Germany

GSK Clinical Trials Call Centre, Vellmar, Baden-Wurttemberg 34246, Germany

GSK Clinical Trials Call Centre, Mannheim, Baden-Wurttemberg 68161, Germany

GSK Clinical Trials Call Centre, Stockach, Baden-Wurttemberg 78333, Germany

GSK Clinical Trials Call Centre, Sabadell, Barcelona 08208, Spain

GSK Clinical Trials Call Centre, Munchen, Bayern 81373, Germany

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

GSK Clinical Trials Call Centre, Kunzing, Bayern 94550, Germany

GSK Clinical Trials Call Centre, Munchen, Bayern 81549, Germany

GSK Clinical Trials Call Centre, Munchen, Bayern 80469, Germany

GSK Clinical Trials Call Centre, PIERRE-BENITE, Bourbonnais 69495, France

GSK Clinical Trials Call Centre, LYON cedex 03, Bourgogne 69394, France

GSK Clinical Trials Call Centre, Potsdam, Brandenburg 14467, Germany

GSK Clinical Trials Call Centre, Schwedt, Brandenburg 16303, Germany

GSK Clinical Trials Call Centre, Falkensee, Brandenburg 14612, Germany

GSK Clinical Trials Call Centre, NANTES CEDEX 1, Brittany 44093, France

GSK Clinical Trials Call Centre, Saint Malo cedex, Brittany 35403, France

GSK Clinical Trials Call Centre, Rennes, Brittany 35000, France

GSK Clinical Trials Call Centre, Reims cedex, Champagne 51092, France

GSK Clinical Trials Call Centre, Parma, Emilia Romagna 35128, Italy

GSK Clinical Trials Call Centre, Epinay Sur Orge, Essone 91360, France

GSK Clinical Trials Call Centre, DOUAI, Flandres 59500, France

GSK Clinical Trials Call Centre, ROUBAIX CEDEX 1, Flandres 59056, France

GSK Clinical Trials Call Centre, Schluchtern, Hessen 36381, Germany

GSK Clinical Trials Call Centre, Frankfurt, Hessen 60326, Germany

GSK Clinical Trials Call Centre, CHOLET, Ile De France 49300, France

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

GSK Clinical Trials Call Centre, BONDY, Limousin 93140, France

GSK Clinical Trials Call Centre, Montbrison, Loire 42600, France

GSK Clinical Trials Call Centre, DOMMARTIN LES TOUL, Lorraine et les Trois-Evehes 54201, France

GSK Clinical Trials Call Centre, Mostoles, Madrid 28935, Spain

GSK Clinical Trials Call Centre, Llantrisant, Mid Glamorgan CF72 8XR, United Kingdom

GSK Clinical Trials Call Centre, Hildesheim, Niedersachsen 31139, Germany

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

GSK Clinical Trials Call Centre, Aachen, Nordrhein-Westfalen 52070, Germany

GSK Clinical Trials Call Centre, Koln, Nordrhein-Westfalen 51065, Germany

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

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

GSK Clinical Trials Call Centre, Viersen, Nordrhein-Westfalen 41751, Germany

GSK Clinical Trials Call Centre, Koln, Nordrhein-Westfalen 50823, Germany

GSK Clinical Trials Call Centre, Neuss, Nordrhein-Westfalen 41466, Germany

GSK Clinical Trials Call Centre, Kettering, Northants NN16 8UZ, United Kingdom

GSK Clinical Trials Call Centre, Worksop, Nottinghamshire S81 0BD, United Kingdom

GSK Clinical Trials Call Centre, Corbeil Essonnes, Orleanais 91100, France

GSK Clinical Trials Call Centre, Altenkirchen, Rheinland-Pfailz 57610, Germany

GSK Clinical Trials Call Centre, Bosenheim, Rheinland-Pfailz 55545, Germany

GSK Clinical Trials Call Centre, Ludwigshafen, Rheinland-Pfailz 67061, Germany

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

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

GSK Clinical Trials Call Centre, Freital, Sachsen 1705, Germany

GSK Clinical Trials Call Centre, Dresden, Sachsen 1307, Germany

GSK Clinical Trials Call Centre, Pirna, Sachsen 1796, Germany

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

GSK Clinical Trials Call Centre, Halle, Sachsen-Anhalt 6114, Germany

GSK Clinical Trials Call Centre, Halle, Sachsen-Anhalt 6112, Germany

GSK Clinical Trials Call Centre, LA ROCHELLE CEDEX 1, Saintonge 17019, France

GSK Clinical Trials Call Centre, Barnsley, South Yorkshire S75 2EP, United Kingdom

GSK Clinical Trials Call Centre, Schleiz, Thuringen 7907, Germany

GSK Clinical Trials Call Centre, PERUGIA, Umbria 06126, Italy

GSK Clinical Trials Call Centre, PADOVA, Veneto 35128, Italy

GSK Clinical Trials Call Centre, Pordenone, Veneto 33170, Italy

GSK Clinical Trials Call Centre, Treviso, Veneto 31100, Italy

GSK Clinical Trials Call Centre, Baracaldo, Vizcaya 48903, Spain

GSK Clinical Trials Call Centre, Galdacano, Vizcaya 48960, Spain

GSK Clinical Trials Call Centre, Livingstone, West Lothian EH54 6PP, United Kingdom

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

GSK Clinical Trials Call Centre, Bad Oeynhausen, Westfalen-Lippe 32549, Germany

Starting date: October 2003
Last updated: June 12, 2007