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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tablets, Oral, once daily
Advanced Clinical Research Institute
Anaheim, California, United States
Elite Research Institute
Miami, Florida, United States
Prism Research
Saint Paul, Minnesota, United States
Dgd Research, Inc.
San Antonio, Texas, United States
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
Time frame: on Days -1, 1, 4 and 10
Blood samples for serum glucose and creatinine will be collected
Time frame: on Days -1, 1, 4 and 10 at selected timepoints
Blood and urine PK samples
Time frame: on Days 1, 4, 10
Iohexol PK blood & urine samples for GFR assessment
Time frame: on Day -12 to -5
AEs, vital signs
Time frame: scr, Days -1, 1, 4-11, discharge
physical exams
Time frame: scr, Days -12 to -5, -1, discharge
ECGs
Time frame: scr, Days,-1, 4, 7, discharge
clinical labs
Time frame: 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)
Time frame: on Days -1, 1, 4 and 10
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