A Phase 1 interventional study of Dapagliflozin in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 4 sites in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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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:
50 mg single dose
Drug: Dapagliflozin
20 mg up to 7 days
Drug: Dapagliflozin
Tablets, Oral, once daily
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
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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