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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of derivation of pharmacokinetic variables | Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP). | plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Golor | Parexel | Principal Investigator |
| Thomas Koernicke | Parexel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25511685 | Derived | Tang W, Reele S, Hamer-Maansson JE, Parikh S, de Bruin TW. Dapagliflozin twice daily or once daily: effect on pharmacokinetics and urinary glucose excretion in healthy subjects. Diabetes Obes Metab. 2015 Apr;17(4):423-5. doi: 10.1111/dom.12425. Epub 2015 Jan 12. |
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| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Dapagliflozin | Drug | Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days |
|
| To examine the safety and tolerability of the combination of dapagliflozin and metformin | Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later |