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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days
Research Site
Berlin, Germany
Calculation of derivation of pharmacokinetic variables
Time frame: 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
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).
Time frame: 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
To examine the safety and tolerability of the combination of dapagliflozin and metformin
Time frame: Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later
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