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This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK Activator (2) | Drug | 100mg po bid |
| |
| Glyburide |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-6h of plasma glucose | Days -1, 6 and 12 | |
| AUC0-12h of GK Activator (2) and metabolite. | Days 6 and 12 | |
| AUC0-tau of glyburide | Days -1 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, 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 |
|---|---|---|---|---|---|---|
| Cypress | California | 90630 | United States | |||
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
10-20mg po daily |
|
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| Buffalo | New York | NY 14215 | United States |
| San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |