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This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO4876904 1 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
|
| RO4876904 2 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
|
| RO4876904 3 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
|
| RO4876904 4 | Experimental | Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
|
| Placebo | Placebo Comparator | Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo po daily. |
| |
| RO4876904 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in hemoglobin A1c (HbA1c) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. | Week 12 | |
| Adverse events (AEs), vital signs, laboratory parameters. | Throughout study |
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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 |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | 71913 | United States | |||
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| Drug |
Escalating doses, at a starting dose of 12.5mg po daily. |
|
| Concord |
| California |
| 94520 |
| United States |
| Los Angeles | California | 90057 | United States |
| Chicago | Illinois | 60607 | United States |
| Avon | Indiana | 46123 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Oxon Hill | Maryland | 20745 | United States |
| Troy | Michigan | 48098 | United States |
| Omaha | Nebraska | 68154 | United States |
| Binghamton | New York | 13901 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Adelaide | 5000 | Australia |
| Canberra | 2605 | Australia |
| St Leonards | 2065 | Australia |
| São Paulo | 01244-030 | Brazil |
| São Paulo | 04022-001 | Brazil |
| Guatemala City | 01015 | Guatemala |
| Hong Kong | Hong Kong |
| Aguascalientes | 20230 | Mexico |
| Chihuahua City | 31238 | Mexico |
| Guadalajara | 44650 | Mexico |
| Guadalajara | 45200 | Mexico |
| Mexico City | 11650 | Mexico |
| Pachuca | 42086 | Mexico |
| Tampico | 89109 | Mexico |
| Moscow | 109263 | Russia |
| Moscow | 117036 | Russia |
| Moscow | 121069 | Russia |
| Moscow | 125315 | Russia |
| Moscow | 129110 | Russia |
| Saint Petersburg | 195112 | Russia |
| Saint Petersburg | 195213 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197198 | Russia |
| Saratov | 410038 | Russia |
| Yaroslavl | 150010 | Russia |
| Yaroslavl | 150062 | Russia |
| Alzira | 46600 | Spain |
| Bacarot Alicant | 03114 | Spain |
| Badalona | Spain |
| Barcelona | 08022 | Spain |
| Ferrol | 15405 | Spain |
| Bath | BA1 2SR | United Kingdom |
| Frome | BA11 1EZ | United Kingdom |
| Glasgow | G45 9AW | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| Motherwell | ML1 3JX | 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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