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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 2.5 mg |
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| Arm 2 | Experimental | 10 mg |
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| Arm 3 | Experimental | 20 mg |
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| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, once daily up, to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs, vital signs & physical exam | scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 | |
| ECGs | scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21 | |
| Clinical labs | scr, Days -1, 2, 7, 12, 14, 15, 21 | |
| Urine safety markers | Days -1, 1, 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hr PK blood & urine samples | Days 1 & 14 | |
| Serum glucose, serum insulin, serum c-peptide | Days -1, 1, 14 | |
| Serum fructosamine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Suita | Osaka | 5650853 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21226818 | Result | Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x. |
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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 |
|---|---|
| C529054 | dapagliflozin |
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| placebo | Drug | Tablets, Oral, 0 mg, once daily, up to 14 days |
|
| Days -1, 14, 4 h |
| OGTT | Days -2, 13 (after 10 h fast) |
| 24h urine | Days -1, 1 & 14 for glucose, creatinine & calcium |
| D004700 | Endocrine System Diseases |