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This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK Activator (2) | Drug | Escalating doses po bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c mean change from baseline, compared to placebo. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional parameters of glycemic and lipid control. | Week 12 | |
| AEs, laboratory parameters. | Throughout study | |
| Pharmacokinetic and exposure-response relationship |
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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 |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85723 | United States | |||
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| Placebo |
| Drug |
po bid |
|
| Throughout study |
| Pine Bluff |
| Arkansas |
| 71603 |
| United States |
| Chula Vista | California | 91911 | United States |
| Spring Valley | California | 91978 | United States |
| West Hills | California | 91307 | United States |
| Hollywood | Florida | 33021 | United States |
| Atlanta | Georgia | 30308 | 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 |
| Tipton | Pennsylvania | 16684 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Plano | Texas | 75093 | United States |
| Renton | Washington | 98055 | United States |
| Dimitrovgrad | 6400 | Bulgaria |
| Pleven | 5800 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1303 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Zagreb | 10000 | Croatia |
| Guatemala City | 01015 | Guatemala |
| Budapest | 1083 | Hungary |
| Budapest | 1088 | Hungary |
| Győr | 9024 | Hungary |
| Kecskemét | 6000 | Hungary |
| Chihuahua City | 31238 | Mexico |
| Cuernavaca | 62250 | 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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