An Open Label Phase IV Study to Evaluate Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function

Diabetes Mellitus, Type 2 Clinical Trial

Official title: DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is an open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. The study population is as described below. The maximum duration of the study will be 62 days including the allowed window periods for the study (±1 day for Visit 7 at Day 13). The study will allow for an up to 6-week Screening and Run-in Period. The Run-in Period should always last 6 days for patients not on insulin but may be up to 20 days (day -20 to day -1) for patients on insulin. Patients on insulin may require a longer Run-in Period in order to be able to adjust their insulin requirements according to the caloric content of the food boxes, if needed. It is recommended to keep the insulin dose stable during the trial, but investigators can change the dose if medically required. However, it is not mandatory for the patient on insulin to use the entire extended Run-in Period. Based on the Investigator's judgement, the Run-in Period may be shortened once each patient (on insulin) has had sufficient time to adapt to the food boxes, and it is determined that the patient's insulin requirement has stabilised sufficiently to continue in the study. The study will then include a 2-week Treatment Period (Day 1 to Day 14) and a 5-day Follow-up Period: Day 15 to Day 19. Patients will consume food from standardised food boxes (with sodium content 150 mmol) 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Impaired Renal Function
• Renal Insufficiency

• NCT number: NCT04620590
• Study type: Interventional
• Source: George Clinical Pty Ltd
• Contact: Suzanne M Milne, BS, MBA
• Phone: 1-901-390-0306
• Email: smilne@georgeclinical.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 20, 2021
• Completion date: April 15, 2022