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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001765-28 |
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This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks 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 1 year, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| taspoglutide 10mg sc | Experimental |
| |
| taspoglutide 10mg/20mg sc | 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 |
|---|---|---|
| Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. | Throughout study | |
| Change from baseline in fasting plasma glucose; change from baseline in body weight. | 24 weeks |
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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 | 85015 | United States | |||
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| Drug |
10mg sc, once weekly |
|
| taspoglutide | Drug | 20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) |
|
| Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function. | 24 weeks |
| Los Angeles |
| California |
| 90057 |
| United States |
| Santa Ana | California | 92701 | United States |
| Avon | Indiana | 46123 | United States |
| Pahrump | Nevada | 89048 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Greer | South Carolina | 29651 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| San Antonio | Texas | 78237 | United States |
| Richmond | Virginia | 23294 | United States |
| Adelaide | 5000 | Australia |
| St Leonards | 2065 | Australia |
| Guatemala City | 01010 | Guatemala |
| Guatemala City | 01014 | Guatemala |
| Haifa | 31096 | Israel |
| Haifa | 34162 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91200 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Tel Aviv | 64239 | Israel |
| Acapulco | 39670 | Mexico |
| Aguascalientes | 20230 | Mexico |
| Chihuahua City | 31238 | Mexico |
| Hermosillo | 83200 | Mexico |
| Mexico City | 11650 | Mexico |
| Morelia | 58000 | Mexico |
| Lima | Lima 33 | Peru |
| San Isidro | 27 | Peru |
| Bucharest | 020359 | Romania |
| Buzău | 120203 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Ploieşti | 100163 | Romania |
| Ploieşti | 100342 | Romania |
| Tg. Mures | 540142 | Romania |
| Chelyabinsk | 454136 | Russia |
| Jaloslave | Russia |
| Moscow | 109263 | Russia |
| Moscow | 117036 | Russia |
| Moscow | 119048 | Russia |
| Moscow | 129110 | Russia |
| S. Petersburg | 195067 | Russia |
| S.petersburg | 194017 | Russia |
| Saint Petersburg | 191124 | Russia |
| Yaroslavl | 150062 | Russia |
| Dolný Kubín | 02601 | Slovakia |
| Levice | 034 01 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Trenčín | 911 01 | Slovakia |
| Žilina | 010 01 | Slovakia |
| Changhua | 500 | Taiwan |
| Tainan | 710 | Taiwan |
| Taipei | 100 | Taiwan |
| Tapei County | 231 | Taiwan |
| Chernivtsi | 58002 | Ukraine |
| Kiev | 01601 | Ukraine |
| Kiev | 04050 | Ukraine |
| Lviv | 79010 | Ukraine |
| 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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