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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001854-42 |
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This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses. |
|
| Sitagliptin | Active Comparator | Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses. |
|
| Taspoglutide 10 mg | Experimental | Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses. |
|
| Taspoglutide up-titrated to 20 mg | Experimental | Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | As prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes 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%); responder rates for body weight; change from baseline in lipid profile; beta cell function. | 24 weeks | |
| Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
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| Placebo (matching sitagliptin) | Drug | Once daily oral administration of placebo (matching sitagliptin). |
|
| Placebo (matching taspoglutide) | Drug | Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide). |
|
| Sitagliptin | Drug | Once daily oral administration of 100 mg of sitagliptin. |
|
| Taspoglutide | Drug | Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide. |
|
| Throughout study |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| Tallassee | Alabama | 36078 | United States |
| Scottsdale | Arizona | 85254 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Huntington Beach | California | 92646 | United States |
| La Jolla | California | 92037 | United States |
| Los Angeles | California | 90017 | United States |
| Roseville | California | 95661 | United States |
| San Francisco | California | 94109 | United States |
| Tacoma | California | 98405 | United States |
| Colorado Springs | Colorado | 80904 | United States |
| New London | Connecticut | 06320 | United States |
| Manati | District of Columbia | 00674 | United States |
| Daytona Beach | Florida | 32117 | United States |
| Hialeah | Florida | 33012 | United States |
| Jacksonville | Florida | 32205 | United States |
| Miami | Florida | 33186 | United States |
| Panama City | Florida | 32401 | United States |
| Tampa | Florida | 33606 | United States |
| Augusta | Georgia | 30904 | United States |
| Conyers | Georgia | 30094 | United States |
| Snellville | Georgia | 30029 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Indianapolis | Indiana | 46229 | United States |
| Indianapolis | Indiana | 46254 | United States |
| Lafayette | Indiana | 47905 | United States |
| South Bend | Indiana | 46628 | United States |
| Baltimore | Maryland | 21229 | United States |
| Brockton | Massachusetts | 02301 | United States |
| Cadillac | Michigan | 49601 | United States |
| Brooklyn Center | Minnesota | 55430 | United States |
| Minneapolis | Minnesota | 55416 | United States |
| City of Saint Peters | Missouri | 63376 | United States |
| Fulton | New York | 13069 | United States |
| Hudson | New York | 12534 | United States |
| Rochester | New York | 14609 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Shelby | North Carolina | 28150 | United States |
| Statesville | North Carolina | 28625 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Columbus | Ohio | 43213 | United States |
| Delaware | Ohio | 43015 | United States |
| Marion | Ohio | 43302 | United States |
| Corvallis | Oregon | 97330 | United States |
| Eugene | Oregon | 97401 | United States |
| Aliquippa | Pennsylvania | 15001 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Erie | Pennsylvania | 16508 | United States |
| Reading | Pennsylvania | 17601 | United States |
| Reading | Pennsylvania | 19606 | United States |
| Shippensburg | Pennsylvania | 17257 | United States |
| Warminster | Pennsylvania | 18974 | United States |
| Anderson | South Carolina | 29621 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77030 | United States |
| South Burlington | Vermont | 05403 | United States |
| Hampton | Virginia | 23666 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23249 | United States |
| Richmond | Virginia | 23294 | United States |
| Federal Way | Washington | 98003 | United States |
| Buenos Aires | C1012 | Argentina |
| Buenos Aires | C1213AAH | Argentina |
| Mar del Plata | B7600DHK | Argentina |
| Freemantle | Queensland | 6959 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| London | Ontario | N6A 4V2 | Canada |
| Thornhill | Ontario | L4J 8L7 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Bondy | 93143 | France |
| Nantes | 44093 | France |
| Poitiers | 86021 | France |
| Rennes | 35203 | France |
| Saint-Mandé | 94163 | France |
| Berlin | 10115 | Germany |
| Dormagen | 41539 | Germany |
| Dresden | 01307 | Germany |
| Kiel Kronshagen | 24119 | Germany |
| München | 80336 | Germany |
| Sulzbach-Rosenberg | 92237 | Germany |
| Villingen-Schwenningen | 78048 | Germany |
| Larissa | 41110 | Greece |
| Cuernavaca | 62250 | Mexico |
| Hermosillo | 83200 | Mexico |
| Jalisco | 44690 | Mexico |
| Mexico City | 06700 | Mexico |
| Mexico City | 11520 | Mexico |
| Monterrey | 64000 | Mexico |
| Pachuca | 42086 | Mexico |
| Elverum | 2401 | Norway |
| Oslo | 0027 | Norway |
| Oslo | 0176 | Norway |
| Oslo | 0407 | Norway |
| Lima | Lima 33 | Peru |
| Lima | Lima 9 | Peru |
| Bialystok | 15-445 | Poland |
| Gdansk | 80-858 | Poland |
| Kamieniec Ząbkowicki | 57-230 | Poland |
| Rzeszów | 35-073 | Poland |
| Skierniewice | 96-100 | Poland |
| Sobótka | 55-050 | Poland |
| Wroclaw | 51-124 | Poland |
| Caguas | 00725 | Puerto Rico |
| Carolina | 00983 | Puerto Rico |
| Bucharest | 020359 | Romania |
| Buzău | 120203 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Ploieşti | 100163 | Romania |
| Ploieşti | 100342 | Romania |
| Levice | 93405 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Šamorín | 931 01 | Slovakia |
| Trebišov | 07501 | Slovakia |
| Trenčín | 911 01 | Slovakia |
| Cape Town | 7130 | South Africa |
| Pretoria | 0002 | South Africa |
| Gyeonggi-do | 443-380 | South Korea |
| Gyeonggi-do | South Korea |
| Seoul | 152-703 | South Korea |
| Seoul | South Korea |
| Wŏnju | 220-701 | South Korea |
| Bacarot Alicant | Alicante | 03114 | Spain |
| Almería | Almeria | 04001 | Spain |
| Seville | Sevilla | 41010 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Ljungby | 34182 | Sweden |
| Örebro | 701 85 | Sweden |
| Stockholm | 14186 | Sweden |
| Basel | 4031 | Switzerland |
| Geneva | 1211 | Switzerland |
| Zurich | 8063 | Switzerland |
| Taichung | 407 | Taiwan |
| Taipei | 114 | Taiwan |
| Taipei | 220 | Taiwan |
| Taoyuan County | 333 | Taiwan |
| Bangkok | 10330 | Thailand |
| Songkhla | 90112 | Thailand |
| Istanbul | 34390 | Turkey (Türkiye) |
| Bexhill-on-Sea | TN39 4SP | United Kingdom |
| Crawley | RH10 7DX | United Kingdom |
| Glasgow | G46 8NY | 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 |
|---|---|
| D008687 | Metformin |
| D000068900 | Sitagliptin Phosphate |
| C541736 | taspoglutide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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