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This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. 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 |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK Activator (2) | Drug | Escalating doses bid |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, laboratory parameters, ECG. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from original baseline in HbA1c, FPG, lipid profile. | 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 |
|---|---|---|---|---|---|---|
| Chula Vista | California | 91910 | United States | |||
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| Drug |
As prescribed, in patients who were in study BM18249 |
|
| Chula Vista |
| California |
| 91911 |
| United States |
| Los Angeles | California | 90057 | United States |
| Spring Valley | California | 91978 | United States |
| West Hills | California | 91307 | United States |
| Hollywood | Florida | 33021 | United States |
| Kissimmee | Florida | 34741 | United States |
| Atlanta | Georgia | 30308 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Butte | Montana | 59701 | United States |
| Binghamton | New York | 13901 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Statesville | North Carolina | 28625 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Springdale | Ohio | 45246 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Medford | Oregon | 97504 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Memphis | Tennessee | 38119 | United States |
| Federal Way | Washington | 98003 | United States |
| Renton | Washington | 98055 | United States |
| Camperdown | 2050 | Australia |
| Heidelberg | 3081 | Australia |
| Dimitrovgrad | 6400 | Bulgaria |
| Pleven | 5800 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| London | Ontario | NGA 4V2 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Zagreb | 10000 | Croatia |
| Bammental | 69245 | Germany |
| Berlin | 10115 | Germany |
| Essen | 45355 | Germany |
| Giessen | 35385 | Germany |
| Görlitz | 02826 | Germany |
| Hamburg | 20249 | Germany |
| Künzing | 94550 | Germany |
| Nuremberg | 90402 | Germany |
| Tann | 36142 | Germany |
| Guatemala City | 01015 | Guatemala |
| Budapest | 1083 | Hungary |
| Győr | 9024 | Hungary |
| Kecskemét | 6000 | Hungary |
| Chihuahua City | 31238 | Mexico |
| Cuernavaca | 62270 | Mexico |
| Durango | 34070 | Mexico |
| Mexico City | 06700 | Mexico |
| Mexico City | 11650 | Mexico |
| Mexico City | 14050 | Mexico |
| Mexico City | 14610 | Mexico |
| Bialystok | 15-276 | Poland |
| Gdansk | 80-757 | Poland |
| Gorzów | 66-400 | Poland |
| Krakow | 31-121 | Poland |
| Wroclaw | 50-088 | Poland |
| 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 |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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