Trial Outcomes & Findings for The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function. (NCT NCT03152084)
NCT ID: NCT03152084
Last Updated: 2021-05-28
Results Overview
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.
TERMINATED
PHASE4
24 participants
From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4)
2021-05-28
Participant Flow
The study was conducted between 12-Jul-2017 and 20-Mar-2020. Patients who met all the inclusion and none of the exclusion criteria were enrolled in the study.
All study assessments were performed as per the schedule of assessment. No patients in Group 1 were enrolled into the Run-in set due to failure to meet inclusion exclusion criteria, screen failure, or other reasons. Due to unsatisfactory recruitment rate, it was decided that no more Group 1 patients would be enrolled in the study. Group 1 included type 2 diabetes mellitus (T2DM) patients with impaired kidney function and were to receive oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14.
Participant milestones
| Measure |
Group 2
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
7
|
|
Overall Study
COMPLETED
|
17
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
Baseline characteristics by cohort
| Measure |
Group 2
n=17 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=7 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 80 years
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4)Population: 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.
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.
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Sodium Excretion From Baseline to Start of Treatment
|
-5.33 mmol/24 hour
Interval -53.667 to 44.0
|
-27.67 mmol/24 hour
Interval -69.334 to 13.334
|
SECONDARY outcome
Timeframe: From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14); and from end of treatment (Day 12 to 14) to follow-up (Day 15 to 17)Population: 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).
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up
End of treatment vs baseline
|
2.67 mmol/24 hour
Interval -64.0 to 143.167
|
-23.83 mmol/24 hour
Interval -107.0 to 0.667
|
|
Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up
Follow-up vs end of treatment
|
1.33 mmol/24 hour
Interval -135.334 to 25.0
|
6.17 mmol/24 hour
Interval -70.333 to 20.333
|
SECONDARY outcome
Timeframe: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to 4)Population: 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 start of treatment values (Day 2 to 4).
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=5 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Glucose Excretion From Baseline to Start of Treatment
|
302.61 mmol/24 hour
Interval 191.472 to 635.726
|
43.93 mmol/24 hour
Interval 12.05 to 132.333
|
SECONDARY outcome
Timeframe: From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14)Population: 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)
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=4 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Glucose Excretion From Baseline to End of Treatment
|
283.40 mmol/24 hour
Interval 155.876 to 762.801
|
29.88 mmol/24 hour
Interval 15.45 to 113.3
|
SECONDARY outcome
Timeframe: From end of treatment (Day 12 to 14) to follow-up (Day 15 to 17)Population: 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).
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=5 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Glucose Excretion From End of Treatment to Follow-up
|
-168.43 mmol/24 hour
Interval -376.561 to -107.596
|
-37.02 mmol/24 hour
Interval -74.733 to -10.584
|
SECONDARY outcome
Timeframe: From baseline (Day -1) to start of treatment (Day 4)Population: 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)
Outcome measures
| Measure |
Group 2
n=13 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment
|
-5.4810 mmHg
Interval -13.661 to 5.61
|
-8.9730 mmHg
Interval -24.657 to 2.721
|
SECONDARY outcome
Timeframe: From baseline (Day -1) to end of treatment (Day 13)Population: 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).
Outcome measures
| Measure |
Group 2
n=12 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment
|
-5.9385 mmHg
Interval -16.006 to 0.916
|
-10.3290 mmHg
Interval -23.416 to 16.216
|
SECONDARY outcome
Timeframe: From end of treatment (Day 13) to end of follow-up (Day 18)Population: 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).
Outcome measures
| Measure |
Group 2
n=11 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=5 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up
|
2.5140 mmHg
Interval -10.342 to 8.459
|
-2.6590 mmHg
Interval -16.311 to 7.468
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to start of treatment (Day 4)Population: 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).
Outcome measures
| Measure |
Group 2
n=13 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=3 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Plasma Volume From Baseline to Start of Treatment
|
-0.1440 Litres
Interval -1.7819 to 2.6385
|
-0.1139 Litres
Interval -2.034 to 0.0232
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to end of treatment (Day 14)Population: 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).
Outcome measures
| Measure |
Group 2
n=11 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=1 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Plasma Volume From Baseline to End of Treatment
|
-0.2122 Litres
Interval -2.8346 to 1.1073
|
2.0557 Litres
Interval 2.0557 to 2.0557
|
SECONDARY outcome
Timeframe: From end of treatment (Day 14) to end of follow-up (Day 18)Population: 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).
Outcome measures
| Measure |
Group 2
n=12 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Plasma Volume From End of Treatment to End of Follow-up
|
0.6464 Litres
Interval -1.5016 to 1.641
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to start of treatment (Day 4)Population: 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).
Outcome measures
| Measure |
Group 2
n=14 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Extracellular Volume From Baseline to Start of Treatment
|
-0.5783 Litres
Interval -2.7027 to 0.7959
|
-0.4553 Litres
Interval -1.3758 to 0.2282
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to end of treatment (Day 14)Population: 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).
Outcome measures
| Measure |
Group 2
n=13 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Extracellular Volume From Baseline to End of Treatment
|
0.1248 Litres
Interval -1.4948 to 0.9852
|
-0.1427 Litres
Interval -0.6101 to 1.0055
|
SECONDARY outcome
Timeframe: From end of treatment (Day 14) to end of follow-up (Day 18)Population: 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).
Outcome measures
| Measure |
Group 2
n=13 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in Extracellular Volume From End of Treatment to End of Follow-up
|
0.1784 Litres
Interval -0.6507 to 0.978
|
0.1394 Litres
Interval -0.3045 to 0.9014
|
SECONDARY outcome
Timeframe: From baseline (Day -3 to Day -1) to start of treatment (Day 4); and from baseline (Day -3 to Day-1) to end of treatment (Day 12 to 14)Population: 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 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).
Outcome measures
| Measure |
Group 2
n=15 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=6 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
Start of treatment vs baseline
|
-0.07 mg/mmol
Interval -30.75 to 6.7
|
-5.83 mg/mmol
Interval -35.3 to 0.3
|
|
Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
End of treatment vs baseline
|
-0.04 mg/mmol
Interval -17.25 to 0.737
|
-7.28 mg/mmol
Interval -35.733 to 0.467
|
|
Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
Follow-up vs end of treatment
|
0.07 mg/mmol
Interval -0.243 to 51.667
|
-0.19 mg/mmol
Interval -2.967 to 6.367
|
SECONDARY outcome
Timeframe: At pre-dose (Day 4) and at pre-dose, 1h, 2h, 4h post-dose (Day 14)Population: 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.
Dapagliflozin plasma concentration on Day 4 (pre-dose) and Day 14 (pre-dose, 1h, 2h, 4h post-dose)
Outcome measures
| Measure |
Group 2
n=17 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=7 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Day 4, Pre-dose
|
4.58 ng/mL
Geometric Coefficient of Variation 134.88
|
19.78 ng/mL
Geometric Coefficient of Variation 116.54
|
|
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Day 14, Pre-dose
|
4.54 ng/mL
Geometric Coefficient of Variation 46.60
|
15.26 ng/mL
Geometric Coefficient of Variation 41.97
|
|
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Day 14, 1 h
|
57.46 ng/mL
Geometric Coefficient of Variation 110.66
|
63.83 ng/mL
Geometric Coefficient of Variation 150.41
|
|
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Day 14, 2 h
|
46.47 ng/mL
Geometric Coefficient of Variation 49.30
|
60.41 ng/mL
Geometric Coefficient of Variation 140.69
|
|
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Day 14, 4 h
|
29.71 ng/mL
Geometric Coefficient of Variation 47.38
|
47.83 ng/mL
Geometric Coefficient of Variation 100.41
|
SECONDARY outcome
Timeframe: From Day 1 until Day 18 (Follow-up)Population: 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.
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.
Outcome measures
| Measure |
Group 2
n=17 Participants
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=7 Participants
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Number of Patients With AEs and SAEs
Any AE
|
6 Patients
|
2 Patients
|
|
Number of Patients With AEs and SAEs
AEs judged as causally related to dapagliflozin
|
4 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
AEs leading to death
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
SAEs (including outcomes = death)
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
SAEs causally related to dapagliflozin
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
AEs leading to permanent discontinuation of dapagliflozin
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
SAEs leading to permanent discontinuation of dapagliflozin
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
Hypoglycaemia AEs
|
0 Patients
|
0 Patients
|
|
Number of Patients With AEs and SAEs
Hypoglycaemia AEs leading to permanent discontinuation of dapagliflozin
|
0 Patients
|
0 Patients
|
Adverse Events
Group 2
Group 3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 2
n=17 participants at risk
Type 2 diabetes mellitus (T2DM) patients with preserved kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
Group 3
n=7 participants at risk
Non-diabetic patients with impaired kidney function received oral dose of dapagliflozin 10 mg/day from Day 1 to Day 14, following which they entered Follow-up Period from Day 15 to Day 19.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
14.3%
1/7 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 2 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Infections and infestations
Genital infection
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
14.3%
1/7 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Nervous system disorders
Head discomfort
|
11.8%
2/17 • Number of events 2 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
|
Vascular disorders
Haematoma
|
5.9%
1/17 • Number of events 1 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
0.00%
0/7 • Day 1 until Day 18 (FU)
SAEs and non-SAEs are reported for the Safety Set which comprised of all patients who received at least one dose of study drug and who had data from at least one post-dose safety assessment available.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Results disclosure agreements
- Principal investigator is a sponsor employee Study results are Sponsor's intellectual property and PIs cannot present or publish results without prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER