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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005809-20 |
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This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| taspoglutide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | sc once weekly |
| |
| taspoglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight;% of patients achieving >=5% weight loss | 24 weeks | |
| % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function |
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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 |
|---|---|---|---|---|---|---|
| Bermuda Dunes | California | 92203 | United States | |||
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| Drug |
10mg sc once weekly for 4 weeks, then 20mg sc once weekly |
|
| 24 weeks |
| Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n | At planned clinic visits, for 12 months |
| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90057 | United States |
| Mission Viejo | California | 92691 | United States |
| Brooksville | Florida | 34601 | United States |
| Miami | Florida | 33133 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Atlanta | Georgia | 30342 | United States |
| Chicago | Illinois | 60607 | United States |
| Avon | Indiana | 46123 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Bangor | Maine | 04401 | United States |
| Royal Oak | Michigan | 48073 | United States |
| Picayune | Mississippi | 39466 | United States |
| Clifton | New Jersey | 07012 | United States |
| Toms River | New Jersey | 08753 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| New York | New York | 10025 | United States |
| Springfield Gardens | New York | 11413 | United States |
| Charlotte | North Carolina | 28277 | United States |
| Shelby | North Carolina | 28150 | United States |
| Norman | Oklahoma | 73069 | United States |
| Medford | Oregon | 97504 | United States |
| Clinton | South Carolina | 29325 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77074 | United States |
| Midland | Texas | 79707 | United States |
| San Antonio | Texas | 78237 | United States |
| Vancouver | British Columbia | V5Z 1L8 | Canada |
| Sherbrooke | Nova Scotia | J1G 2E8 | Canada |
| Etobicoke | Ontario | M9R 4E1 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| Oakville | Ontario | L6H 3P1 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Aschaffenburg | 63739 | Germany |
| Berlin | 10115 | Germany |
| Bochum | 44791 | Germany |
| Dortmund | 44137 | Germany |
| Dresden | 01307 | Germany |
| Falkensee | 14612 | Germany |
| Mainz | 55116 | Germany |
| Münster | 48145 | Germany |
| Neuwied | 56564 | Germany |
| Ancona | 60131 | Italy |
| Ravenna | 48100 | Italy |
| Roma | 00161 | Italy |
| Siena | 53100 | Italy |
| Bitola | 7000 | North Macedonia |
| Gniewkowo | 88-140 | Poland |
| Kamieniec Ząbkowicki | 57-230 | Poland |
| Lublin | 20-044 | Poland |
| Carolina | 00983 | Puerto Rico |
| Rio Grande | 00745 | Puerto Rico |
| Rio Piedras | 00921 | Puerto Rico |
| Kemerovo | 650002 | Russia |
| Moscow | 105229 | Russia |
| Moscow | 115280 | Russia |
| Moscow | 117036 | Russia |
| Ryazan | 390026 | Russia |
| Saratov | 410002 | Russia |
| Smolensk | 214019 | Russia |
| Tyumen | 625023 | Russia |
| Barcelona | 08036 | Spain |
| Lleida | 25198 | Spain |
| Oviedo | 33006 | Spain |
| Bath | BA2 4BY | United Kingdom |
| Birmingham | B9 5SS | United Kingdom |
| Glasgow | G45 9AW | United Kingdom |
| Midsomer Norton | BA3 2UH | United Kingdom |
| Rotherham | S65 1DA | 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 |
|---|---|
| C541736 | taspoglutide |
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