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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009157-24 |
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This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Active Comparator |
| |
| taspoglutide 10mg | Experimental | taspoglutide 10mg sc weekly |
|
| taspoglutide 10mg/20mg | Experimental | taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | 30mg po once daily for 4 weeks, followed by 45mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving target HbA1c <=6.5%, <=7% | weeks 24, 52 and 104 | |
| Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buena Park | California | 90620 | United States | |||
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| taspoglutide |
| Drug |
10mg sc once weekly |
|
| taspoglutide | Drug | 10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly |
|
| weeks 24, 52 and 104 |
| Adverse events; laboratory parameters; cardiovascular events | At each clinic visit up to 106 weeks |
| Chino |
| California |
| 91710 |
| United States |
| Los Angeles | California | 90057 | United States |
| Rancho Cucamonga | California | 91730 | United States |
| Roseville | California | 95661 | United States |
| Santa Ana | California | 92701 | United States |
| Chiefland | Florida | 32626 | United States |
| Coral Gables | Florida | 33134 | United States |
| Daytona Beach | Florida | 32117 | United States |
| Panama City | Florida | 32401 | United States |
| Port Charlotte | Florida | 33948 | United States |
| St. Petersburg | Florida | 33716 | United States |
| Winter Park | Florida | 32789 | United States |
| Atlanta | Georgia | 30338 | United States |
| Columbus | Georgia | 31904 | United States |
| Conyers | Georgia | 30094 | United States |
| Roswell | Georgia | 30076 | United States |
| Chicago | Illinois | 60607 | United States |
| Chicago | Illinois | 60610-4319 | United States |
| Springfield | Illinois | 62704-1433 | United States |
| Evansville | Indiana | 47714 | United States |
| Madisonville | Kentucky | 42431 | United States |
| Metairie | Louisiana | 70006 | United States |
| Bethesda | Maryland | 20817 | United States |
| Ayer | Massachusetts | 01432 | United States |
| Waltham | Massachusetts | 02453 | United States |
| Ferndale | Michigan | 48220 | United States |
| Minneapolis | Minnesota | 55416 | United States |
| Biloxi | Mississippi | 39531 | United States |
| Jackson | Mississippi | 39216 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Grand Island | Nebraska | 68803 | United States |
| Berlin | New Jersey | 08009 | United States |
| Brick | New Jersey | 08724 | United States |
| Toms River | New Jersey | 08753 | United States |
| Trenton | New Jersey | 08611 | United States |
| New York | New York | 10021 | United States |
| Staten Island | New York | 10301 | United States |
| Durham | North Carolina | 27713 | United States |
| Mooresville | North Carolina | 28117 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Bend | Oregon | 97701 | United States |
| Medford | Oregon | 97504 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Scranton | Pennsylvania | 18510 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77074 | United States |
| Salt Lake City | Utah | 84107 | United States |
| South Burlington | Vermont | 05403 | United States |
| Richmond | Virginia | 23226 | United States |
| Richmond | Virginia | 23249 | United States |
| Spokane | Washington | 99202 | United States |
| Vancouver | Washington | 98664 | United States |
| Waukesha | Wisconsin | 53189 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Wollongong | New South Wales | 2500 | Australia |
| Fortaleza | Ceará | 60430-370 | Brazil |
| Lago Sul | Federal District | 71625009 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Marília | São Paulo | 17519030 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 01244-030 | Brazil |
| São Paulo | São Paulo | 04020-050 | Brazil |
| São Paulo | São Paulo | 04022-001 | Brazil |
| Sorocaba | São Paulo | 18047-360 | Brazil |
| Vancouver | British Columbia | V6H 3X8 | Canada |
| Etobicoke | Ontario | M9R 4E1 | Canada |
| London | Ontario | N6A 5R8 | Canada |
| Thornhill | Ontario | L4J 8L7 | Canada |
| Toronto | Ontario | M4G 3E8 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| San José | 4395-1000 | Costa Rica |
| San José | 755-1000 | Costa Rica |
| Besançon | 25030 | France |
| Corbeil-Essonnes | 91106 | France |
| Dommartin-lès-Toul | 54200 | France |
| La Rochelle | 17019 | France |
| Lille | 59037 | France |
| Poitiers | 86021 | France |
| Vénissieux | 69200 | France |
| Berlin | 10115 | Germany |
| Essen | 45359 | Germany |
| Falkensee | 14612 | Germany |
| Mainz | 55116 | Germany |
| Münster | 48145 | Germany |
| Rodgau | 63110 | Germany |
| Siegen | 57074 | Germany |
| Sulzbach-Rosenberg | 92237 | Germany |
| Wangen | 88239 | Germany |
| Aguascaliente | 20230 | Mexico |
| Celaya | 38000 | Mexico |
| Cuernavaca | 62250 | Mexico |
| Guadalajara | 44100 | Mexico |
| Guadalajara | 44650 | Mexico |
| Mexico City | 06700 | Mexico |
| Monterrey | 64460 | Mexico |
| Auckland | 1640 | New Zealand |
| Auckland | New Zealand |
| San Isidro | 27 | Peru |
| Gdansk | 80-858 | Poland |
| Krakow | 30-015 | Poland |
| Krakow | 31-455 | Poland |
| Lublin | 20-044 | Poland |
| Lublin | 20-538 | Poland |
| Wroclaw | 50-044 | Poland |
| Rio Piedras | 00926 | Puerto Rico |
| Moscow | 117036 | Russia |
| Moscow | 121069 | Russia |
| Moscow | 127299 | Russia |
| Penza | 440026 | Russia |
| S.Petersburg | 194017 | Russia |
| Saint Petersburg | 193012 | Russia |
| Saint Petersburg | 194156 | Russia |
| Saint Petersburg | 194354 | Russia |
| Saint Petersburg | 195057 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saratov | 140018 | Russia |
| Voronezh | 394018 | Russia |
| Yaroslavl | 150023 | Russia |
| Yaroslavl | 150062 | Russia |
| Bratislava | 851 01 | Slovakia |
| Dolný Kubín | 026 01 | Slovakia |
| Levice | 034 01 | Slovakia |
| Levice | 93405 | Slovakia |
| Cape Town | 7130 | South Africa |
| Almería | Almeria | 04001 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Pamplona | Navarre | 31008 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Chiang Mai | 50200 | Thailand |
| Pathum Thani | 12120 | Thailand |
| Songkhla | 90112 | Thailand |
| Kiev | 04050 | Ukraine |
| Odesa | 65009 | Ukraine |
| Odesa | 65117 | Ukraine |
| Vinnitsa | 21010 | Ukraine |
| Atherstone | CV9 1EU | United Kingdom |
| Birmingham | B9 5SS | United Kingdom |
| Chesterfield | S40 4TF | United Kingdom |
| Dumfries | DG1 4AP | United Kingdom |
| Glasgow | G45 9AW | United Kingdom |
| Hinckley | LE10 2SE | United Kingdom |
| Reading | RG7 3SQ | United Kingdom |
| 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 |
|---|---|
| D000077205 | Pioglitazone |
| C541736 | taspoglutide |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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