Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Overview[ - collapse ][ - ]
| Purpose | The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Rosiglitazone Drug: glyburide Drug: metformin |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00279045 |
| First Received | January 17, 2006 |
| Last Updated | April 11, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 17, 2006 |
|---|---|
| Last Updated Date | April 11, 2013 |
| Start Date | January 2000 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Time from randomization to the primary action point (monotherapy failure). |
| Current Secondary Outcome Measures | Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP). |
Descriptive Information[ + expand ][ + ]
| Brief Title | Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide |
|---|---|
| Official Title | A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus |
| Brief Summary | The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus. |
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Rosiglitazone Drug: glyburide Drug: metformin Other Names:
|
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 4100 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion criteria: - Newly diagnosed patients (< 3years) with type 2 diabetes. - Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening. - No previous treatment with oral or parenteral glucose-lowering therapy. Exclusion criteria: - History of lactic acidosis. - Anemia (<11g for males, <10 g for females). - Unstable or severe NY Heart Association-class 3 or 4. - Any NY Heart Association congestive heart failure. - Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids. |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Belgium, Czech Republic, France, Germany, Netherlands, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00279045 |
|---|---|
| Other Study ID Numbers | 49653/048 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Vienna, Austria, 1130 Wien |
|---|---|
| GSK Investigational Site | Vienna, Austria, A-1080 |
| GSK Investigational Site | Wiener Neustadt, Austria, A-2700 |
| GSK Investigational Site | Blankenberge, Belgium, 8370 |
| GSK Investigational Site | Boechout, Belgium, 2530 |
| GSK Investigational Site | Deurne, Belgium, 2100 |
| GSK Investigational Site | Leuven, Belgium, B-3000 |
| GSK Investigational Site | Lubbeek (Linden), Belgium, B-3210 |
| GSK Investigational Site | Tielt, Belgium, 8700 |
| GSK Investigational Site | Wezembeek-Oppem, Belgium, B-1970 |
| GSK Investigational Site | Wijnegem, Belgium, 2110 |
| GSK Investigational Site | Zernst, Belgium, 1980 |
| GSK Investigational Site | Ostrava, Czech Republic, 703 52 |
| GSK Investigational Site | Phaha 5, Czech Republic, 150 06 |
| GSK Investigational Site | Praha 4, Czech Republic, 142 00 |
| GSK Investigational Site | Usti Nad Labem, Czech Republic, 401 13 |
| GSK Investigational Site | Zlin, Czech Republic, 762 75 |
| GSK Investigational Site | Alben, France, 73410 |
| GSK Investigational Site | Bezier, France, 34500 |
| GSK Investigational Site | Bourges, France, 18000 |
| GSK Investigational Site | Brogile, France, 27270 |
| GSK Investigational Site | Chartres, France, 28000 |
| GSK Investigational Site | Denguin, France, 64230 |
| GSK Investigational Site | Evreux, France, 27000 |
| GSK Investigational Site | Gamarde Les Bains, France, 40380 |
| GSK Investigational Site | La Rochelle, France, 17000 |
| GSK Investigational Site | Labarthe Sur Leze, France, 31860 |
| GSK Investigational Site | Le Mans, France, 72000 |
| GSK Investigational Site | Le Pian Medoc, France, 33290 |
| GSK Investigational Site | Lille, France, 59000 |
| GSK Investigational Site | Mallemort, France, 13370 |
| GSK Investigational Site | Marseille, France, 13008 |
| GSK Investigational Site | Marseille, France, 13001 |
| GSK Investigational Site | Marsillargues, France, 34590 |
| GSK Investigational Site | Marssac, France, 81150 |
| GSK Investigational Site | Mont de Marsen, France, 40000 |
| GSK Investigational Site | Montignac, France, 24290 |
| GSK Investigational Site | Moulon, France, 33420 |
| GSK Investigational Site | Murs Erigne, France, 49610 |
| GSK Investigational Site | Nantes, France, 44300 |
| GSK Investigational Site | Nimes, France, 30900 |
| GSK Investigational Site | Orthez, France, 64300 |
| GSK Investigational Site | Paris, France, 75015 |
| GSK Investigational Site | Rennes, France, 35200 |
| GSK Investigational Site | Roanna, France, 42300 |
| GSK Investigational Site | Saint Etienne, France, 42000 |
| GSK Investigational Site | Sisteron, France, 04200 |
| GSK Investigational Site | St Genies Des Fontaines, France, 66740 |
| GSK Investigational Site | St Julien Des Landes, France, 85150 |
| GSK Investigational Site | St Martin D'Heres, France, 38400 |
| GSK Investigational Site | St Pierre de Chandieu, France, 69780 |
| GSK Investigational Site | Strasbourg, France, 67000 |
| GSK Investigational Site | Tarare, France, 69170 |
| GSK Investigational Site | Vieux Conde, France, 59690 |
| GSK Investigational Site | Vourey, France, 38210 |
| GSK Investigational Site | Ismaning, Bayern, Germany, 85737 |
| GSK Investigational Site | Muenchen, Bayern, Germany, 81379 |
| GSK Investigational Site | Offenbach, Hessen, Germany, 63065 |
| GSK Investigational Site | Paderborn, Niedersachsen, Germany, 33100 |
| GSK Investigational Site | Goch, Nordrhein-Westfalen, Germany, 47574 |
| GSK Investigational Site | Berlin, Germany, 13355 |
| GSK Investigational Site | Geleen, Netherlands, 6166 GR |
| GSK Investigational Site | Huizen, Netherlands, 1271 BB |
| GSK Investigational Site | Losser, Netherlands, 7582 BD |
| GSK Investigational Site | Albaida (Valencia), Spain |
| GSK Investigational Site | Cartagena, Spain, 30203 |
| GSK Investigational Site | Cáceres, Spain, 10005 |
| GSK Investigational Site | Madrid, Spain, 28006 |
| GSK Investigational Site | Olleria, Valencia, Spain, 46850 |
| GSK Investigational Site | Sagunto/Valencia, Spain, 46520 |
| GSK Investigational Site | Tenerife, Spain, 38010 |
| GSK Investigational Site | Tereul, Spain, 44002 |
| GSK Investigational Site | Toledo, Spain, 45004 |
| GSK Investigational Site | Torrelavega/Santander, Spain, 39300 |
| GSK Investigational Site | Valencia, Spain, 46017 |
| GSK Investigational Site | Valencia, Spain |
| GSK Investigational Site | Valencia, Spain, 46830 |
| GSK Investigational Site | Villajoyosa - Alicante, Spain, 03570 |
| GSK Investigational Site | Alta, Sweden, 138 21 |
| GSK Investigational Site | Degerberga, Sweden, 297 31 |
| GSK Investigational Site | Gimo, Sweden, SE-747 43 |
| GSK Investigational Site | Malmö, Sweden, SE-214 26 |
| GSK Investigational Site | Stockholm, Sweden, SE-114 35 |
| GSK Investigational Site | Reading, Berkshire, United Kingdom, RG2 7AG |
| GSK Investigational Site | Airdrie, Lanarkshire, United Kingdom, ML6 0JS |
| GSK Investigational Site | Edinburgh, Midlothian, United Kingdom, EH3 9YW |
| GSK Investigational Site | Livingston, West Lothian, United Kingdom, EH54 6PP |
| GSK Investigational Site | Glasgow, United Kingdom, G51 4TF |
| GSK Investigational Site | Glenrothes, United Kingdom |