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The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone maleate/metformin hydrochloride | Drug | rosiglitazone maleate/metformin hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hemoglobin A1c (HbA1c) at week 32. | at 32 week |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks | at 32 weeksInvalid value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 712753/007 | Informed Consent Form | View IPD |
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| Chandler |
| Arizona |
| 85224 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85014 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85050 | United States |
| GSK Investigational Site | Tucson | Arizona | 85745 | United States |
| GSK Investigational Site | Encinitas | California | 92024 | United States |
| GSK Investigational Site | Fullerton | California | 92835 | United States |
| GSK Investigational Site | Los Banos | California | 93635 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32204 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Saint Cloud | Florida | 34769 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Fayetteville | Georgia | 30214 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30189 | United States |
| GSK Investigational Site | Chicago | Illinois | 60607 | United States |
| GSK Investigational Site | Evansville | Indiana | 47713 | United States |
| GSK Investigational Site | Newburgh | Indiana | 47630 | United States |
| GSK Investigational Site | Slidell | Louisiana | 70461 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | St Louis | Missouri | 63376 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89103 | United States |
| GSK Investigational Site | Kingston | New York | 12401 | United States |
| GSK Investigational Site | New York | New York | 10024 | United States |
| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28210 | United States |
| GSK Investigational Site | Mogadore | Ohio | 44260 | United States |
| GSK Investigational Site | Downingtown | Pennsylvania | 19335 | United States |
| GSK Investigational Site | Warminster | Pennsylvania | 18974 | United States |
| GSK Investigational Site | West Chester | Pennsylvania | 19382 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37601 | United States |
| GSK Investigational Site | Arlington | Texas | 76017 | United States |
| GSK Investigational Site | Beaumont | Texas | 77701 | United States |
| GSK Investigational Site | Bryan | Texas | 77802 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Midland | Texas | 79705 | United States |
| GSK Investigational Site | San Antonio | Texas | 78221 | United States |
| GSK Investigational Site | San Antonio | Texas | 78237 | United States |
| GSK Investigational Site | Seattle | Washington | 98108 | United States |
| GSK Investigational Site | Spokane | Washington | 99207 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| GSK Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Woolloongabba | Queensland | 4102 | Australia |
| GSK Investigational Site | North Adelaide | South Australia | 5006 | Australia |
| GSK Investigational Site | Caulfield | Victoria | 3162 | Australia |
| GSK Investigational Site | Fremantle | Western Australia | 6959 | Australia |
| GSK Investigational Site | Perth | Western Australia | 6000 | Australia |
| GSK Investigational Site | Recife | Pernambuco | 50100-130 | Brazil |
| GSK Investigational Site | São Paulo | 04020-041 | Brazil |
| GSK Investigational Site | Calgary | Alberta | T3E 0C5 | Canada |
| GSK Investigational Site | Coquitlam | British Columbia | V3K 3V9 | Canada |
| GSK Investigational Site | Langley | British Columbia | V3A 4H9 | Canada |
| GSK Investigational Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 5R3 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3T1 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7M 4Y1 | Canada |
| GSK Investigational Site | Courtice | Ontario | L1E 3C3 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2C 2N9 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 2H3 | Canada |
| GSK Investigational Site | Oshawa | Ontario | L1H 1C2 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9H 5G1 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9J 7B3 | Canada |
| GSK Investigational Site | Renfrew | Ontario | K7V 1P6 | Canada |
| GSK Investigational Site | Stoney Creek | Ontario | L8G 2V6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3J 1N2 | Canada |
| GSK Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1V 1X4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3S 2W1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4N 2W2 | Canada |
| GSK Investigational Site | Plessisville | Quebec | G6L 3J1 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Saint Insidore de Dorchester | Quebec | G0S 2S0 | Canada |
| GSK Investigational Site | Saint-Marc-des-Carrieres | Quebec | G0A 4B0 | Canada |
| GSK Investigational Site | Sainte Jerome | Quebec | J7Z 5T3 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Regina | Saskatchewan | S4S 0A2 | Canada |
| GSK Investigational Site | Regina | Saskatchewan | S4S 3R8 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 0M5 | Canada |
| GSK Investigational Site | Tijuana | Baja California Norte | 22320 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64570 | Mexico |
| GSK Investigational Site | Durango | 3400 | Mexico |
| GSK Investigational Site | Mexico City | 11850 | Mexico |
| GSK Investigational Site | Mexico City | 14050 | Mexico |
| GSK Investigational Site | Auckland | 1311 | New Zealand |
| GSK Investigational Site | Auckland | 1701 | New Zealand |
| GSK Investigational Site | Christchurch | 8001 | New Zealand |
| GSK Investigational Site | Rotorua | 3201 | New Zealand |
| GSK Investigational Site | Wellington | 6035 | New Zealand |
| GSK Investigational Site | Pusan | 602-739 | South Korea |
| GSK Investigational Site | Seoul | 139-872 | South Korea |
| GSK Investigational Site | Uijeongbu-si | 480-821 | South Korea |
For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 712753/007 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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