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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 50 mg single dose |
|
| Arm 2 | Experimental | 20 mg up to 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine | on Days -1, 1, 4 and 10 | |
| Blood samples for serum glucose and creatinine will be collected | on Days -1, 1, 4 and 10 at selected timepoints | |
| Blood and urine PK samples | on Days 1, 4, 10 | |
| Iohexol PK blood & urine samples for GFR assessment | on Day -12 to -5 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, vital signs | scr, Days -1, 1, 4-11, discharge | |
| physical exams | scr, Days -12 to -5, -1, discharge | |
| ECGs |
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Key Inclusion Criteria:
Group A: Healthy Subjects with Normal Renal Function (CLcr > 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr > 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr > 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr < 30 mL/min) (and not receiving dialysis)
Standard Exclusion Criteria, plus:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Elite Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23210765 | Result | Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056. |
| Label | URL |
|---|---|
| MB102007 \_Redacted \_CSR \_synopsis | View source |
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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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| scr, Days,-1, 4, 7, discharge |
| clinical labs | scr, Day -1, 1, 4, 6, 8, 10, discharge |
| The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only) | on Days -1, 1, 4 and 10 |
| Miami |
| Florida |
| 33169 |
| United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
| Dgd Research, Inc. | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |