AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes. |
|---|---|
| Condition | Non-Insulin-Dependent Diabetes Mellitus |
| Intervention | Drug: metformin Drug: sulphonylurea Drug: Avandamet |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00359112 |
| First Received | July 28, 2006 |
| Last Updated | May 15, 2009 |
| Last verified | May 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 28, 2006 |
|---|---|
| Last Updated Date | May 15, 2009 |
| Start Date | February 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Change in HbA1c level from baseline following 52 weeks of treatment. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Non-Insulin-Dependent Diabetes Mellitus |
| Intervention | Drug: metformin Drug: sulphonylurea Drug: Avandamet Other Names:
|
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 544 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Belgium, France, Germany, Ireland, Italy, Lithuania, Mexico, Netherlands, Spain, Switzerland, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00359112 |
|---|---|
| Other Study ID Numbers | AVM100264 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials, DM, FRCP GlaxoSmithKline |
| Verification Date | May 2009 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Brugge, Belgium, 8000 |
|---|---|
| GSK Investigational Site | Bruxelles, Belgium, 1210 |
| GSK Investigational Site | Bruxelles, Belgium, 1030 |
| GSK Investigational Site | Heverlee, Belgium, 3001 |
| GSK Investigational Site | Landen, Belgium, 3400 |
| GSK Investigational Site | Namur (Champion), Belgium, 5020 |
| GSK Investigational Site | Oostham, Belgium, 3945 |
| GSK Investigational Site | Petit-Rechain, Belgium, 4800 |
| GSK Investigational Site | Tessenderlo, Belgium, 3980 |
| GSK Investigational Site | Tremelo, Belgium, 3120 |
| GSK Investigational Site | Willebroek, Belgium, 2830 |
| GSK Investigational Site | Zandhoven (Pulle), Belgium, 2243 |
| GSK Investigational Site | Roubaix, Nord-Pas-de-Calais, France, 59100 |
| GSK Investigational Site | Anzin, France, 59410 |
| GSK Investigational Site | Briollay, France, 49125 |
| GSK Investigational Site | Commelle Vernay, France, 42120 |
| GSK Investigational Site | Cremeaux, France, 42260 |
| GSK Investigational Site | Evron, France, 53600 |
| GSK Investigational Site | Laval, France, 53000 |
| GSK Investigational Site | Louverne, France, 53950 |
| GSK Investigational Site | Lyon, France, 69007 |
| GSK Investigational Site | Paris, France, 75015 |
| GSK Investigational Site | Roanne, France, 42300 |
| GSK Investigational Site | Saint Ouen, France, 93400 |
| GSK Investigational Site | Sainte Suzanne, France, 53270 |
| GSK Investigational Site | Segré, France, 49500 |
| GSK Investigational Site | Venissieux, France, 69200 |
| GSK Investigational Site | Gueglingen, Baden-Wuerttemberg, Germany, 74363 |
| GSK Investigational Site | Kippenheim, Baden-Wuerttemberg, Germany, 77971 |
| GSK Investigational Site | Koenigsfeld, Baden-Wuerttemberg, Germany, 78126 |
| GSK Investigational Site | Waldshut-Tiengen, Baden-Wuerttemberg, Germany, 79961 |
| GSK Investigational Site | Weinheim, Baden-Wuerttemberg, Germany, 69469 |
| GSK Investigational Site | Grafing, Bayern, Germany, 85567 |
| GSK Investigational Site | Herzogenaurach, Bayern, Germany, 91074 |
| GSK Investigational Site | Immenstadt, Bayern, Germany, 87509 |
| GSK Investigational Site | Oberteisendorf, Bayern, Germany, 83317 |
| GSK Investigational Site | Saaldorf-Surheim, Bayern, Germany, 83416 |
| GSK Investigational Site | Wallerfing, Bayern, Germany, 94574 |
| GSK Investigational Site | Wuerzburg, Bayern, Germany, 97072 |
| GSK Investigational Site | Grossalmerode, Hessen, Germany, 37247 |
| GSK Investigational Site | Einbeck, Niedersachsen, Germany, 37574 |
| GSK Investigational Site | Hannover, Niedersachsen, Germany, 30519 |
| GSK Investigational Site | Isernhagen, Niedersachsen, Germany, 30916 |
| GSK Investigational Site | Papenburg, Niedersachsen, Germany, 26871 |
| GSK Investigational Site | Beckum, Nordrhein-Westfalen, Germany, 59269 |
| GSK Investigational Site | Bergkamen-Rünthe, Nordrhein-Westfalen, Germany, 59192 |
| GSK Investigational Site | Bochum, Nordrhein-Westfalen, Germany, 44869 |
| GSK Investigational Site | Dinslaken, Nordrhein-Westfalen, Germany, 46537 |
| GSK Investigational Site | Dortmund, Nordrhein-Westfalen, Germany, 44137 |
| GSK Investigational Site | Essen, Nordrhein-Westfalen, Germany, 45134 |
| GSK Investigational Site | Essen, Nordrhein-Westfalen, Germany, 45359 |
| GSK Investigational Site | Goch, Nordrhein-Westfalen, Germany, 47574 |
| GSK Investigational Site | Koeln, Nordrhein-Westfalen, Germany, 51069 |
| GSK Investigational Site | Viersen, Nordrhein-Westfalen, Germany, 41749 |
| GSK Investigational Site | Mainz, Rheinland-Pfalz, Germany, 55116 |
| GSK Investigational Site | Neuwied, Rheinland-Pfalz, Germany, 56564 |
| GSK Investigational Site | Rhaunen, Rheinland-Pfalz, Germany, 55624 |
| GSK Investigational Site | Speyer, Rheinland-Pfalz, Germany, 67346 |
| GSK Investigational Site | Saarlouis, Saarland, Germany, 66740 |
| GSK Investigational Site | Wolmirstedt, Sachsen-Anhalt, Germany, 39326 |
| GSK Investigational Site | Dresden, Sachsen, Germany, 01219 |
| GSK Investigational Site | Elmshorn, Schleswig-Holstein, Germany, 25335 |
| GSK Investigational Site | Blanchardstown, Ireland, 15 |
| GSK Investigational Site | Dublin, Ireland, 8 |
| GSK Investigational Site | Dublin, Ireland, 9 |
| GSK Investigational Site | Bologna, Emilia-Romagna, Italy, 40138 |
| GSK Investigational Site | Ferrara, Emilia-Romagna, Italy, 44100 |
| GSK Investigational Site | Ravenna, Emilia-Romagna, Italy, 48100 |
| GSK Investigational Site | Arenzano (GE), Liguria, Italy, 16011 |
| GSK Investigational Site | Genova, Liguria, Italy, 16132 |
| GSK Investigational Site | Sassari, Sardegna, Italy, 07100 |
| GSK Investigational Site | Città di Castello (PG), Umbria, Italy, 06012 |
| GSK Investigational Site | Terni, Umbria, Italy, 05100 |
| GSK Investigational Site | Kaunas, Lithuania, LT-44320 |
| GSK Investigational Site | Kaunas, Lithuania, LT-49335 |
| GSK Investigational Site | Vilnius, Lithuania, LT-07156 |
| GSK Investigational Site | Vilnius, Lithuania, LT-08661 |
| GSK Investigational Site | Tijuana, Baja California Norte, Mexico, 22320 |
| GSK Investigational Site | Pachuca, Hidalgo, Mexico, 42039 |
| GSK Investigational Site | Guadalajara, Jalisco, Mexico, 44340 |
| GSK Investigational Site | Durango, Mexico, 3400 |
| GSK Investigational Site | Mexico, D.F., Mexico, 11850 |
| GSK Investigational Site | Beek En Donk, Netherlands, 5741 CG |
| GSK Investigational Site | Beerzerveld, Netherlands, 7685 PG |
| GSK Investigational Site | Den Haag, Netherlands, 2582 LJ |
| GSK Investigational Site | Heerlen, Netherlands, 6416 EG |
| GSK Investigational Site | Hoogvliet, Netherlands, 3192 JN |
| GSK Investigational Site | Landgraaf, Netherlands, 6373 JS |
| GSK Investigational Site | Musselkanaal, Netherlands, 9581 AJ |
| GSK Investigational Site | Oude Pekela, Netherlands, 9665 AR |
| GSK Investigational Site | Spijkenisse, Netherlands, 3207 NB |
| GSK Investigational Site | Woerden, Netherlands, 3443 GG |
| GSK Investigational Site | Zaandam, Netherlands, 1504 JA |
| GSK Investigational Site | Zieuwent, Netherlands, 7136 KH |
| GSK Investigational Site | Alcobendas/Madrid, Spain, 28100 |
| GSK Investigational Site | Alcora/Castellón, Spain, 12110 |
| GSK Investigational Site | Alicante, Spain |
| GSK Investigational Site | Alzira, Spain, 46600 |
| GSK Investigational Site | Artana/Castellón, Spain, 12527 |
| GSK Investigational Site | Barcelona, Spain, 08015 |
| GSK Investigational Site | Barcelona, Spain, 08022 |
| GSK Investigational Site | Benicassim (Castellon), Spain |
| GSK Investigational Site | Cadiz, Spain, 11009 |
| GSK Investigational Site | Castellón, Spain |
| GSK Investigational Site | Cáceres, Spain, 10004 |
| GSK Investigational Site | Gerona, Spain |
| GSK Investigational Site | Granada, Spain, 18014 |
| GSK Investigational Site | Madrid, Spain, 28034 |
| GSK Investigational Site | Madrid, Spain, 28041 |
| GSK Investigational Site | Madrid, Spain, 28037 |
| GSK Investigational Site | Madrid, Spain, 28046 |
| GSK Investigational Site | Malaga, Spain, 29009 |
| GSK Investigational Site | Merida, Spain, 6800 |
| GSK Investigational Site | Móstoles/Madrid, Spain, 28935 |
| GSK Investigational Site | Onda (Castellon), Spain |
| GSK Investigational Site | Pontevedra, Spain, 36002 |
| GSK Investigational Site | Sabadell (Barcelona), Spain, 08208 |
| GSK Investigational Site | San Juan De Alicante, Spain, 3550 |
| GSK Investigational Site | Sta Coloma de Gramanet (Barcelona), Spain, 08923 |
| GSK Investigational Site | Tarrasa, Barcelona, Spain, 08221 |
| GSK Investigational Site | Valencia, Spain, 46010 |
| GSK Investigational Site | Bern, Switzerland, 3007 |
| GSK Investigational Site | Emmenbrücke, Switzerland, 6020 |
| GSK Investigational Site | Gettnau, Switzerland, 6142 |
| GSK Investigational Site | Jegenstorf, Switzerland, 3303 |
| GSK Investigational Site | Lugano, Switzerland, 6900 |
| GSK Investigational Site | Luzern, Switzerland, 6004 |
| GSK Investigational Site | Pregassona, Switzerland, 6963 |
| GSK Investigational Site | Salmsach, Switzerland, 8599 |
| GSK Investigational Site | St. Maurice, Switzerland, 1890 |
| GSK Investigational Site | Steckborn, Switzerland, 8266 |
| GSK Investigational Site | Winterthur, Switzerland, 8405 |
| GSK Investigational Site | Winterthur, Switzerland, 8400 |
| GSK Investigational Site | Zürich, Switzerland, 8050 |
| GSK Investigational Site | Zürich, Switzerland, 8046 |
| GSK Investigational Site | Glasgow, Lanarkshire, United Kingdom, G69 7AD |
| GSK Investigational Site | Glasgow, Lanarkshire, United Kingdom, G3 8YJ |
| GSK Investigational Site | Blackpool, Lancashire, United Kingdom, FY4 3AD |
| GSK Investigational Site | Bath, Somerset, United Kingdom, BA1 3NG |
| GSK Investigational Site | Bristol, United Kingdom, BS2 8HW |
| GSK Investigational Site | Leeds, United Kingdom, LS12 1JE |
| GSK Investigational Site | Sheffield, United Kingdom, S5 7AU |