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This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-403 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-403, glucokinase activator; oral | Drug | multiple dose, escalating |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | Duration of study | |
| Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT). | 10 days | |
| Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. | 10 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research | Chula Vista | California | 91911 | United States | ||
| Cetero |
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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 |
|---|---|
| C000611842 | ARRY-403 |
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| Placebo; oral |
| Drug |
matching placebo |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| D004700 | Endocrine System Diseases |