Dapagliflozin Treatment in Type 2 Diabetes

Part of paid clinical trials in Aurora, Colorado.

Sponsor: Emerald Clinical Inc.
Study ID: NCT04620590
Phase: PHASE4
Status: Completed

Conditions

Diabetes Mellitus, Type 2
Impaired Renal Function

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10 MG [Farxiga] — DRUG
Dapagliflozin is a stable, reversible, highly selective, and orally active inhibitor of human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for glucose reabsorption in the kidney. Patients will receive one tablet dapagliflozin 10 mg per day for a total period of 14±1 days. This dose is the recommended dose for monotherapy and for add-on combination therapy with other glucose-lowering medicinal products including insulin to improve glycaemic control in T2DM.

Study Details

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.