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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSP-8658 | Experimental | DSP-8658 2.5, 10, 20, 40 mg once daily |
|
| Placebo | Placebo Comparator | Placebo 2.5, 10, 20, and 40 mg doses once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSP-8658 | Drug | Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments include physical examination, laboratory variables and ECG. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study. | 20 days | |
| Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study. |
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Inclusion Criteria: Diabetic subjects
Inclusion Criteria: Healthy subjects
Exclusion Criteria: Diabetic subjects
Exclusion Criteria: Healthy subjects
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo |
| Drug |
Placebo 2.5, 10, 20, 40 mg orally once daily |
|
| 18 days |