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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001855-23 |
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This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin glargine | Active Comparator | insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment |
|
| taspoglutide 10 mg | Experimental | taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment |
|
| taspoglutide 10 mg/20 mg | Experimental | taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin glargine | Drug | starting dose 10 IU daily |
| |
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile. | 24 weeks | |
| Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85032 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22937895 | Derived | Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003. |
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| Drug |
As prescribed |
|
| taspoglutide | Drug | 10 mg once weekly |
|
| taspoglutide | Drug | 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) |
|
| 24 weeks |
| Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies | Throughout study |
| Searcy |
| Arkansas |
| 72143 |
| United States |
| Concord | California | 94520 | United States |
| Huntington Beach | California | 92648 | United States |
| Los Angeles | California | 90015 | United States |
| Los Angeles | California | 90025 | United States |
| Los Gatos | California | 95032 | United States |
| Roseville | California | 95661 | United States |
| San Diego | California | 92109 | United States |
| Santa Ana | California | 92705 | United States |
| Westlake Village | California | 91361 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Green Cove Springs | Florida | 32043 | United States |
| Hialeah | Florida | 33013 | United States |
| Jacksonville | Florida | 32204 | United States |
| Jacksonville | Florida | 32216 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Oviedo | Florida | 32765 | United States |
| Palm Harbor | Florida | 34684 | United States |
| Trinity | Florida | 34655 | United States |
| Zephyrhills | Florida | 33542 | United States |
| Atlanta | Georgia | 30338 | United States |
| Quincy | Illinois | 62301 | United States |
| Springfield | Illinois | 62704-1433 | United States |
| Avon | Indiana | 46123 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Metairie | Louisiana | 70006 | United States |
| Sunset | Louisiana | 70584 | United States |
| Portland | Maine | 04101 | United States |
| North East | Maryland | 21901 | United States |
| Worchester | Massachusetts | 01605 | United States |
| Saint Claire Shores | Michigan | 48081 | United States |
| Jackson | Mississippi | 39216 | United States |
| Picayune | Mississippi | 39466 | United States |
| Springfield | Missouri | 65807 | United States |
| Grand Island | Nebraska | 68803 | United States |
| Omaha | Nebraska | 68105 | United States |
| Omaha | Nebraska | 68131 | United States |
| Henderson | Nevada | 89014 | United States |
| Blackwood | New Jersey | 08012 | United States |
| Cherry Hill | New Jersey | 08002 | United States |
| Moorestown | New Jersey | 08057 | United States |
| Toms River | New Jersey | 08753 | United States |
| Toms River | New Jersey | 08755 | United States |
| Albany | New York | 12206-1098 | United States |
| Flushing | New York | 11365 | United States |
| Mineola | New York | 11501 | United States |
| Asheville | North Carolina | 28803 | United States |
| Harrisburg | North Carolina | 28075 | United States |
| Fargo | North Dakota | 58103 | United States |
| Centerville | Ohio | 45459 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Genoa | Ohio | 43430-1143 | United States |
| Toledo | Ohio | 43606 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Bensalem | Pennsylvania | 19020 | United States |
| Feasterville | Pennsylvania | 19053 | United States |
| Harrisburg | Pennsylvania | 17112 | United States |
| Jefferson Hills | Pennsylvania | 15025 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19146 | United States |
| Scranton | Pennsylvania | 18510 | United States |
| Tipton | Pennsylvania | 16684 | United States |
| Orangeburg | South Carolina | 29115 | United States |
| Johnson City | Tennessee | 37604 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75246 | United States |
| Dallas | Texas | 75390 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77030 | United States |
| Richmond | Virginia | 23249 | United States |
| Waukesha | Wisconsin | 53189 | United States |
| St Leonards | New South Wales | 2065 | Australia |
| Wollongong | New South Wales | 2500 | Australia |
| Freemantle | Queensland | 6959 | Australia |
| Graz | 8036 | Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1080 | Austria |
| Vienna | 1130 | Austria |
| Arlon | 6700 | Belgium |
| Bonheiden | 2820 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Campina Grande do Sul | Paraná | 83430-000 | Brazil |
| Curitiba | Paraná | 80030-110 | Brazil |
| Recife | Pernambuco | 52051-380 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| São Paulo | São Paulo | 04022-001 | Brazil |
| Vancouver | British Columbia | V5Z 1L8 | Canada |
| Hamilton | Ontario | L8S 4J9 | Canada |
| London | Ontario | N6A 5R8 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Sherbrooke | Quebec | J1G 5K2 | Canada |
| Brno | 625 00 | Czechia |
| Havířov | 76301 | Czechia |
| Pilsen | 301 00 | Czechia |
| Prague | 180 00 | Czechia |
| Trutnov | 541 01 | Czechia |
| Helsinki | 00150 | Finland |
| Jyväskylä | 40100 | Finland |
| Tampere | 33100 | Finland |
| Avignon | 84902 | France |
| Besançon | 25030 | France |
| Bois-Guillaume | 76233 | France |
| Brest | 29609 | France |
| Corbeil-Essonnes | 91106 | France |
| La Rochelle | 17019 | France |
| Marseille | 13015 | France |
| Marseille | 13385 | France |
| Montpellier | 34295 | France |
| Nîmes | 30029 | France |
| Paris | 75651 | France |
| Paris | 75877 | France |
| Paris | 75908 | France |
| Strasbourg | 67091 | France |
| Vénissieux | 69200 | France |
| Bad Lauterberg im Harz | 37431 | Germany |
| Berlin | 10115 | Germany |
| Bochum | 44869 | Germany |
| Bosenheim | 55545 | Germany |
| Dortmund | 44137 | Germany |
| Falkensee | 14612 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Mainz | 55116 | Germany |
| Offenbach a.M. | 63065 | Germany |
| Reichenbach | 08468 | Germany |
| Würzburg | 97072 | Germany |
| Athens | 10552 | Greece |
| Larissa | 41110 | Greece |
| Thessaloniki | 56429 | Greece |
| Guatemala City | 01010 | Guatemala |
| Hong Kong | Hong Kong |
| Balatonfüred | 8230 | Hungary |
| Budapest | 1045 | Hungary |
| Szekszárd | 7100 | Hungary |
| Naples | Campania | 80100 | Italy |
| Rome | Lazio | 00157 | Italy |
| Codogno | Lombardy | 26845 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20142 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Aguascalientes | 20127 | Mexico |
| Cuernavaca | 62250 | Mexico |
| Monterrey | 64410 | Mexico |
| Tampico | 89000 | Mexico |
| Auckland | 1640 | New Zealand |
| Auckland | New Zealand |
| Arequipa | Cercado | Peru |
| Lima | Lima 1 | Peru |
| Lima | Lima 33 | Peru |
| Trujillo | 13011 | Peru |
| Grodzisk Mazowiecki | 05-825 | Poland |
| Kamieniec Ząbkowicki | 57-230 | Poland |
| Lodz | 93-338 | Poland |
| Rzeszów | 35-073 | Poland |
| Sobótka | 55-050 | Poland |
| Szczecin | 71-455 | Poland |
| Wroclaw | 51-124 | Poland |
| Coimbra | 3000-075 | Portugal |
| Lisbon | 1250-203 | Portugal |
| Lisbon | 1349-019 | Portugal |
| Guyanabo, San Juan | 00920 | Puerto Rico |
| Levittown | 00950 | Puerto Rico |
| Orocovis | 00720 | Puerto Rico |
| Ponce | 00717-322 | Puerto Rico |
| San Juan | 00926-2832 | Puerto Rico |
| Trujillo Alto | 00976 | Puerto Rico |
| Barnaul | 656024 | Russia |
| Chelyabinsk | 454136 | Russia |
| Moscow | 117049 | Russia |
| Moscow | 125299 | Russia |
| Moscow | 129110 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Novosibirsk | 630047 | Russia |
| Omsk | 644021 | Russia |
| Saint Petersburg | 193012 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 194354 | Russia |
| Saint Petersburg | 195213 | Russia |
| Saint Petersburg | 197022 | Russia |
| Tomsk | 643050 | Russia |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Daegu | 700-721 | South Korea |
| Incheon | South Korea |
| Seoul | 137-040 | South Korea |
| Almería | Almeria | 04001 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Granada | Granada | 18012 | Spain |
| Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Seville | Sevilla | 41010 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Alzira | Valencia | 46600 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Valladolid | Valladolid | 47005 | Spain |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Atherstone | CV9 1EU | United Kingdom |
| Chesterfield | S40 4TF | United Kingdom |
| Dumfries | DG1 4AP | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| Sheffield | S18 1RU | 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 |
|---|---|
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| C541736 | taspoglutide |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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