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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Tablets, Oral, once daily up, to 14 days
Tablets, Oral, 0 mg, once daily, up to 14 days
Local Institution
Suita, Osaka, Japan
AEs, vital signs & physical exam
Time frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
Time frame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
Clinical labs
Time frame: scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
Time frame: Days -1, 1, 14
24 hr PK blood & urine samples
Time frame: Days 1 & 14
Serum glucose, serum insulin, serum c-peptide
Time frame: Days -1, 1, 14
Serum fructosamine
Time frame: Days -1, 14, 4 h
OGTT
Time frame: Days -2, 13 (after 10 h fast)
24h urine
Time frame: Days -1, 1 & 14 for glucose, creatinine & calcium
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