Condition: Diabetes Mellitus, Type 2 · Impaired Renal Function · Sponsor: Emerald Clinical Inc.
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. The study will allow for an up to 6-week Screening and Run-in Period, a 2-week Treatment Period and a 5-day Follow-up Period. Patients will consume food from standardized food boxes starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
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| CU Anschutz Medical Campus - Clinical Translational Research Center (CTRC) | Aurora, Colorado, United States | — |
| David Cherney, CM, PhD | Toronto, Ontario, Canada | — |
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Source record: clinicaltrials.gov/study/NCT04620590