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This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. 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 |
| |
| Simvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of GK Activator (2) and simvastatin acid. | Days 1, 8 and 15 | |
| AUC0-6h of plasma glucose from pre-dose to 6h post-dose. | Days 1, 8 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-6h of GK Activator (2) and simvastatin acid | Days 1, 8 and 15 | |
| AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. | Days 1, 8 and 15 | |
| Cmin, tmin, Cmax, tmax, plasma glucose. |
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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 |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78229 | 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 |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
80mg po |
|
| Days 1, 8 and 15 |
| AEs, laboratory parameters. | Throughout study |
| Tacoma |
| Washington |
| 98418 |
| United States |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |