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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001856-36 |
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This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide | Active Comparator |
| |
| taspoglutide 10mg | Experimental |
| |
| taspoglutide 10mg/20mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | 5mg twice daily for 4 weeks followed by 10mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting body weight | 24 weeks | |
| Proportion of patients reaching target HbA1c <=7.0%, <=6.5% | 24 weeks | |
| Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. |
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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 |
|---|---|---|---|---|---|---|
| Haleyville | Alabama | 35565 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23139373 | Derived | Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8. |
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| taspoglutide |
| Drug |
10mg once weekly |
|
| taspoglutide | Drug | 10mg once weekly for 4 weeks followed by 20mg once weekly |
|
| 24 weeks |
| Beta cell function (proinsulin/insulin ratio) | 24 weeks |
| Mobile |
| Alabama |
| 36617 |
| United States |
| Montgomery | Alabama | 36106 | United States |
| Tuscaloosa | Alabama | 35406 | United States |
| Little Rock | Arkansas | 72204 | United States |
| Escondido | California | 92026 | United States |
| La Jolla | California | 92037 | United States |
| Mission Viejo | California | 92691 | United States |
| Orange | California | 92868 | United States |
| Palm Springs | California | 92262 | United States |
| Rancho Cucamonga | California | 91730 | United States |
| Sacramento | California | 95816-5119 | United States |
| San Leandro | California | 94578 | United States |
| Colorado Springs | Colorado | 80904 | United States |
| Daytona Beach | Florida | 32114 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Green Cove Springs | Florida | 32043 | United States |
| Jacksonville | Florida | 32216 | United States |
| Miami Beach | Florida | 33140 | United States |
| Niceville | Florida | 32578 | United States |
| Orlando | Florida | 32804 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30318 | United States |
| Suwanee | Georgia | 30024 | United States |
| Chicago | Illinois | 60607 | United States |
| Chicago | Illinois | 60622 | United States |
| Lombard | Illinois | 60148 | United States |
| Peoria | Illinois | 61625 | United States |
| Evansville | Indiana | 47714 | United States |
| New Albany | Indiana | 47150 | United States |
| Iowa City | Iowa | 52242 | United States |
| Munfordville | Kentucky | 42765 | United States |
| Metairie | Louisiana | 70006 | United States |
| Bangor | Maine | 04401 | United States |
| Baltimore | Maryland | 21209 | United States |
| Bethesda | Maryland | 20817 | United States |
| Rockville | Maryland | 20854 | United States |
| Royal Oak | Michigan | 48073 | United States |
| Jefferson City | Missouri | 65109 | United States |
| Kansas City | Missouri | 64111 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63141 | United States |
| Washington | Missouri | 63090 | United States |
| Omaha | Nebraska | 68114 | United States |
| Concord | New Hampshire | 03301 | United States |
| Trenton | New Jersey | 08611 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| Whitehouse | New Jersey | 08889 | United States |
| Brooklyn | New York | 11203 | United States |
| New York | New York | 10025 | United States |
| Rochester | New York | 14607 | United States |
| Smithtown | New York | 11787 | United States |
| Springfield Gardens | New York | 11413 | United States |
| Staten Island | New York | 10301 | United States |
| Syracuse | New York | 13210 | United States |
| West Seneca | New York | 14224 | United States |
| Westfield | New York | 14787 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Charlotte | North Carolina | 28233 | United States |
| Durham | North Carolina | 27713 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Columbus | Ohio | 43212 | United States |
| Westlake | Ohio | 44145 | United States |
| Medford | Oregon | 97504 | United States |
| Portland | Oregon | 97239 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Norristown | Pennsylvania | 19401 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Red Lion | Pennsylvania | 17356 | United States |
| Providence | Rhode Island | 02908 | United States |
| Clemson | South Carolina | 29631 | United States |
| Columbia | South Carolina | 29201 | United States |
| Hickory Grove | South Carolina | 28602 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Bristol | Tennessee | 37620 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77005 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77074 | United States |
| Richmond | Virginia | 23226 | United States |
| Everett | Washington | 98201 | United States |
| Buenos Aires | 6000 | Argentina |
| Buenos Aires | C1117ABH | Argentina |
| Buenos Aires | C1181ACH | Argentina |
| Camperdown | New South Wales | 2050 | Australia |
| Freemantle | Queensland | 6959 | Australia |
| Goiânia | Goiás | 74043011 | Brazil |
| Curtiba | Paraná | 80030-110 | Brazil |
| Belém | Pará | 66073-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| Mogi Das Cruzes - Sp | São Paulo | 08780-090 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 04022-001 | Brazil |
| Vancouver | British Columbia | V5Z 1L8 | Canada |
| London | Ontario | N6A 5R8 | Canada |
| Toronto | Ontario | M5C 2T2 | Canada |
| Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Ballerup Municipality | 2750 | Denmark |
| Helsinki | 00150 | Finland |
| Kuopio | 70210 | Finland |
| Oulu | 90100 | Finland |
| Turku | 20100 | Finland |
| Corbeil-Essonnes | 91106 | France |
| Dommartin-lès-Toul | 54200 | France |
| Montpellier | 34295 | France |
| Narbonne | 11108 | France |
| Paris | 75475 | France |
| Salouël | 80480 | France |
| Aschaffenburg | 63739 | Germany |
| Berlin | 10115 | Germany |
| Damme | 49401 | Germany |
| Dresden | 01219 | Germany |
| Essen | 45359 | Germany |
| Falkensee | 14612 | Germany |
| Hamburg | 21073 | Germany |
| Hamburg | 22607 | Germany |
| Ludwigshafen | 67059 | Germany |
| Mainz | 55116 | Germany |
| München | 80634 | Germany |
| Münster | 48145 | Germany |
| Neuwied | 56564 | Germany |
| Nuremberg | 90402 | Germany |
| Pirna | 01796 | Germany |
| Rhaunen | 55624 | Germany |
| Villingen-Schwenningen | 78048 | Germany |
| Zwenkau | 04442 | Germany |
| Thessaloniki | 56429 | Greece |
| Thessaloniki | 57010 | Greece |
| Guatemala City | 01000 | Guatemala |
| Guatemala City | 01014 | Guatemala |
| Beersheba | 8410101 | Israel |
| Haifa | 31096 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91200 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Tel Aviv | 64239 | Israel |
| Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Olbia | Sardinia | 07026 | Italy |
| Siena | Tuscany | 53100 | Italy |
| Acapulco | 39670 | Mexico |
| Aguascalientes | 20127 | Mexico |
| Chihuahua City | 31205 | Mexico |
| Durango | 34000 | Mexico |
| Guadalajara | 44600 | Mexico |
| Guadalajara | 44650 | Mexico |
| Monterrey | 64460 | Mexico |
| Monterrey | 64700 | Mexico |
| Tampico | 89000 | Mexico |
| Auckland | 1640 | New Zealand |
| Auckland | New Zealand |
| Arequipa | Cercado | Peru |
| Lima | 41 | Peru |
| Lima | Lima 33 | Peru |
| Ponce | 00716 | Puerto Rico |
| Ponce | 00717-322 | Puerto Rico |
| Barnaul | 656024 | Russia |
| Moscow | 109263 | Russia |
| Moscow | 119048 | Russia |
| Moscow | 119121 | Russia |
| Moscow | 121069 | Russia |
| Moscow | 125299 | Russia |
| Moscow | 125315 | Russia |
| Moscow | 129110 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Novosibirsk | 630047 | Russia |
| Novosibirsk | 630091 | Russia |
| Omsk | 644021 | Russia |
| S. Petersburg | 194291 | Russia |
| S.Petersburg | 194017 | Russia |
| Saint Petersburg | 191124 | Russia |
| Saint Petersburg | 193012 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 194354 | Russia |
| Saint Petersburg | 195213 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saratov | 140018 | Russia |
| Tomsk | 643050 | Russia |
| Yaroslavl | 150010 | Russia |
| Yaroslavl | 150062 | Russia |
| Cape Town | 7130 | South Africa |
| Pretoria | 0002 | South Africa |
| Seoul | 0 | South Korea |
| Seoul | 110-744 | South Korea |
| Bacarot Alicant | Alicante | 03114 | Spain |
| Almería | Almeria | 04001 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Alzira | Valencia | 46600 | Spain |
| Karlstad | 65185 | Sweden |
| Örebro | 701 85 | Sweden |
| Stockholm | 171 76 | Sweden |
| Uppsala | 75185 | Sweden |
| Zurich | 8091 | Switzerland |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Dnipro | 49044 | Ukraine |
| Donetsk | 83003 | Ukraine |
| Kiev | 02091 | Ukraine |
| Lviv | 79010 | Ukraine |
| Odesa | 65009 | Ukraine |
| Odesa | 65117 | Ukraine |
| Simferopol | 95017 | Ukraine |
| Bath | BA1 2SR | United Kingdom |
| Bradford-on-Avon | BA15 1DQ | United Kingdom |
| Glasgow | G45 9AW | United Kingdom |
| Lanarkshire | ML1 3JX | United Kingdom |
| Trowbridge | BA14 8QA | 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 |
|---|---|
| D000077270 | Exenatide |
| C541736 | taspoglutide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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