Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus |
Intervention | Drug: Rosiglitazone/metformin |
Phase | Phase 3 |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT00069836 |
First Received | October 1, 2003 |
Last Updated | February 11, 2013 |
Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | October 1, 2003 |
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Last Updated Date | February 11, 2013 |
Start Date | October 2003 |
Estimated Primary Completion Date | November 2004 |
Current Primary Outcome Measures | Change from baseline in HbA1c [Time Frame: 24 weeks] |
Current Secondary Outcome Measures | Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction [Time Frame: 24 weeks] |
Descriptive Information[ + expand ][ + ]
Brief Title | Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients |
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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 |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Rosiglitazone/metformin Other Names: Rosiglitazone/metformin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 272 |
Estimated Completion Date | November 2004 |
Estimated Primary Completion Date | November 2004 |
Eligibility 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Austria, France, Germany, Italy, Spain |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00069836 |
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Other Study ID Numbers | 712753/009 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | November 2011 |
Locations[ + expand ][ + ]
GSK Investigational Site | Vienna, Austria, A-1030 |
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GSK Investigational Site | Vienna, Austria, A-1060 |
GSK Investigational Site | Roubaix, Nord-Pas-de-Calais, France, 59100 |
GSK Investigational Site | Angers, France, 49000 |
GSK Investigational Site | Bondy Cedex, France, 93143 |
GSK Investigational Site | Cholet, France, 49300 |
GSK Investigational Site | Corbeil Essonnes Cedex, France, 91106 |
GSK Investigational Site | Douai Cedex, France, 59507 |
GSK Investigational Site | Epinay sur Orge, France, 91360 |
GSK Investigational Site | La Rochelle Cedex 1, France, 17019 |
GSK Investigational Site | Lorient, France, 56322 |
GSK Investigational Site | Lyon Cedex 03, France, 69394 |
GSK Investigational Site | Montbrison, France, 42600 |
GSK Investigational Site | Nantes Cedex 1, France, 44093 |
GSK Investigational Site | Paris, France, 75015 |
GSK Investigational Site | Pierre Benite Cedex, France, 69495 |
GSK Investigational Site | Reims Cedex, France, 51092 |
GSK Investigational Site | Rennes Cedex 2, France, 35203 |
GSK Investigational Site | Toul Cedex, France, 54201 |
GSK Investigational Site | Venissieux, France, 69200 |
GSK Investigational Site | Kippenheim, Baden-Wuerttemberg, Germany, 77971 |
GSK Investigational Site | Mannheim, Baden-Wuerttemberg, Germany, 68199 |
GSK Investigational Site | Mannheim, Baden-Wuerttemberg, Germany, 68161 |
GSK Investigational Site | Sinsheim, Baden-Wuerttemberg, Germany, 74889 |
GSK Investigational Site | Stockach, Baden-Wuerttemberg, Germany, 78333 |
GSK Investigational Site | Ilvesheim, Bayern, Germany, 68549 |
GSK Investigational Site | Kuenzing, Bayern, Germany, 94550 |
GSK Investigational Site | Muenchen, Bayern, Germany, 80469 |
GSK Investigational Site | Muenchen, Bayern, Germany, 81549 |
GSK Investigational Site | Muenchen, Bayern, Germany, 81373 |
GSK Investigational Site | Wallerfing, Bayern, Germany, 94574 |
GSK Investigational Site | Falkensee, Brandenburg, Germany, 14612 |
GSK Investigational Site | Potsdam, Brandenburg, Germany, 14467 |
GSK Investigational Site | Schwedt, Brandenburg, Germany, 16303 |
GSK Investigational Site | Bad Kreuznach, Hessen, Germany, 55545 |
GSK Investigational Site | Frankfurt, Hessen, Germany, 60326 |
GSK Investigational Site | Schluechtern, Hessen, Germany, 36381 |
GSK Investigational Site | Vellmar, Hessen, Germany, 34246 |
GSK Investigational Site | Hildesheim, Niedersachsen, Germany, 31139 |
GSK Investigational Site | Aachen, Nordrhein-Westfalen, Germany, 52070 |
GSK Investigational Site | Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549 |
GSK Investigational Site | Beckum, Nordrhein-Westfalen, Germany, 59269 |
GSK Investigational Site | Dortmund, Nordrhein-Westfalen, Germany, 44137 |
GSK Investigational Site | Goch, Nordrhein-Westfalen, Germany, 47574 |
GSK Investigational Site | Koeln, Nordrhein-Westfalen, Germany, 51069 |
GSK Investigational Site | Koeln, Nordrhein-Westfalen, Germany, 51065 |
GSK Investigational Site | Neuss, Nordrhein-Westfalen, Germany, 41466 |
GSK Investigational Site | Viersen, Nordrhein-Westfalen, Germany, 41751 |
GSK Investigational Site | Altenkirchen, Rheinland-Pfalz, Germany, 57610 |
GSK Investigational Site | Ludwigshafen, Rheinland-Pfalz, Germany, 67061 |
GSK Investigational Site | Rhaunen, Rheinland-Pfalz, Germany, 55624 |
GSK Investigational Site | Simmern, Rheinland-Pfalz, Germany, 55469 |
GSK Investigational Site | Speyer, Rheinland-Pfalz, Germany, 67346 |
GSK Investigational Site | Saarlouis, Saarland, Germany, 66740 |
GSK Investigational Site | Halberstadt, Sachsen-Anhalt, Germany, 38820 |
GSK Investigational Site | Halle, Sachsen-Anhalt, Germany, 06112 |
GSK Investigational Site | Halle, Sachsen-Anhalt, Germany, 06114 |
GSK Investigational Site | Dresden, Sachsen, Germany, 01307 |
GSK Investigational Site | Dresden, Sachsen, Germany, 01219 |
GSK Investigational Site | Freital, Sachsen, Germany, 01705 |
GSK Investigational Site | Pirna, Sachsen, Germany, 01796 |
GSK Investigational Site | Gotha, Thueringen, Germany, 99867 |
GSK Investigational Site | Schleiz, Thueringen, Germany, 07907 |
GSK Investigational Site | Berlin, Germany, 12347 |
GSK Investigational Site | Berlin, Germany, 13057 |
GSK Investigational Site | Berlin, Germany, 12351 |
GSK Investigational Site | Berlin, Germany, 10789 |
GSK Investigational Site | Hamburg, Germany, 22607 |
GSK Investigational Site | Hamburg, Germany, 20246 |
GSK Investigational Site | Hamburg, Germany, 22041 |
GSK Investigational Site | Parma, Emilia-Romagna, Italy, 43100 |
GSK Investigational Site | Pordenone, Friuli-Venezia-Giulia, Italy, 33170 |
GSK Investigational Site | Genova, Liguria, Italy, 16132 |
GSK Investigational Site | Perugia, Umbria, Italy, 06126 |
GSK Investigational Site | Padova, Veneto, Italy, 35128 |
GSK Investigational Site | Treviso, Veneto, Italy, 31100 |
GSK Investigational Site | Alcobendas/Madrid, Spain, 28100 |
GSK Investigational Site | Alicante, Spain |
GSK Investigational Site | Barcelona, Spain, 08036 |
GSK Investigational Site | Barcelona, Spain, 08022 |
GSK Investigational Site | Cadiz, Spain, 11009 |
GSK Investigational Site | Galdakano, Spain, 48960 |
GSK Investigational Site | Granada, Spain, 18012 |
GSK Investigational Site | Madrid, Spain, 28034 |
GSK Investigational Site | Madrid, Spain, 28006 |
GSK Investigational Site | Móstoles/Madrid, Spain, 28935 |
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 | Valencia, Spain, 46010 |
GSK Investigational Site | Vigo/Pontevedra, Spain, 36200 |