Change in 24-hour sodium excretion during dapagliflozin treatment between baseline and average of Days 2 to 4 within each study group in patients with T2DM with preserved kidney function and in non-diabetics with impaired kidney function was assessed.

Evaluable patient set: all patients who dispensed at least one dose of study drug. It excluded primary efficacy variable data which may have been affected by protocol deviations as determined by medical monitor or agreed by study team. For Group 3, early termination of the study resulted in 6 evaluable patients. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented.

Average change in 24-hour sodium excretion from average baseline values to average end of treatment values (Day 12 to 14); and from average end of treatment values (Day 12 to 14) to average values during follow-up (Day 15 to 17).

Evaluable patient set: all patients who dispensed at least one dose of study drug. It excluded primary efficacy variable data which may have been affected by protocol deviations as determined by medical monitor or agreed by study team. For Group 3, early termination of the study resulted in 6 evaluable patients. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented.

Average change in 24-hour glucose excretion from average baseline values to average start of treatment values (Day 2 to 4).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Average change in 24-hour glucose excretion from average baseline values to average end of treatment values (Day 12 to 14)

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Average change in 24-hour glucose excretion from average end of treatment values (Day 12 to 14) to average values during follow-up (Day 15 to 17).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in mean 24-hour systolic blood pressure from baseline to start of treatment (Day 4)

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in mean 24-hour systolic blood pressure from baseline to end of treatment (Day 13).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in mean 24-hour systolic blood pressure from end of treatment (Day 13) to end of follow-up (Day 18).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in plasma volume from baseline to start of treatment (Day 4).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in plasma volume from baseline to end of treatment (Day 14).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in plasma volume from end of treatment (Day 14) to end of follow-up (Day 18).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in extracellular volume from baseline to start of treatment (Day 4).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in extracellular volume from baseline to end of treatment (Day 14).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Change in extracellular volume from end of treatment (Day 14) to end of follow-up (Day 18).

Evaluable patient set: all patients who dispensed at least one dose of study drug. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented for Group 3.

Average change in mean 24-hour urine albumin:creatinine ratio (UACR) from average baseline to Day 4; and from average baseline values to average end of treatment values (Day 12 to 14).

Evaluable patient set: all patients who dispensed at least one dose of study drug. It excluded primary efficacy variable data which may have been affected by protocol deviations as determined by medical monitor or agreed by study team. For Group 3, early termination of the study resulted in 6 evaluable patients. Due to insufficient number of patients recruited, no statistical conclusions were derived, and no confidence intervals or p-values are presented.

Dapagliflozin plasma concentration on Day 4 (pre-dose) and Day 14 (pre-dose, 1h, 2h, 4h post-dose)

Pharmacokinetic analysis set: all patients who were dispensed at least one dose of the study drug and for whom at least one of the plasma concentration samples were available and who had no important protocol deviations judged to impact the analysis of the PK data. Here, number analyzed in each row signifies only the patients with available data that were analyzed for that specified time point.

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. SAE is an AE that results in any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a significant medical event.

Safety set: all patients who received at least one dose of study drug and had data from at least one post-dose safety assessment available were included in the safety set.