DAPASALT: 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.
Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT03152084
Collaborator
(none)
24
4
3
32.3
6
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Either Preserved or Impaired Renal Function and Non-Diabetics With Impaired Renal Function
Actual Study Start Date
:
Jul 12, 2017
Actual Primary Completion Date
:
Mar 20, 2020
Actual Study Completion Date
:
Mar 20, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 T2DM subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. |
Drug: Dapagliflozin
The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.
|
| Experimental: Arm 2 T2DM subjects with an eGFR (CKD-EPI) between >90 and ≤130 mL/min/1.73m2 for patients aged 59 or younger, between >85 and ≤130 mL/min/1.73m2 for patients aged 60 to 69, and between >75 and ≤130 mL/min/1.73m2 for patients aged 70 or older at the Screening Visit. |
Drug: Dapagliflozin
The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.
|
| Experimental: Arm 3 Non-diabetic subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. |
Drug: Dapagliflozin
The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.
|
Outcome Measures
Primary Outcome Measures
- Change in 24-hour Sodium Excretion From Baseline to Start of Treatment [From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4)]
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.
Secondary Outcome Measures
- Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up [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)]
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).
- Change in 24-hour Glucose Excretion From Baseline to Start of Treatment [From baseline (Day -3 to Day -1) to start of treatment (Day 2 to 4)]
Average change in 24-hour glucose excretion from average baseline values to average start of treatment values (Day 2 to 4).
- Change in 24-hour Glucose Excretion From Baseline to End of Treatment [From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14)]
Average change in 24-hour glucose excretion from average baseline values to average end of treatment values (Day 12 to 14)
- Change in 24-hour Glucose Excretion From End of Treatment to Follow-up [From end of treatment (Day 12 to 14) to follow-up (Day 15 to 17)]
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).
- Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment [From baseline (Day -1) to start of treatment (Day 4)]
Change in mean 24-hour systolic blood pressure from baseline to start of treatment (Day 4)
- Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment [From baseline (Day -1) to end of treatment (Day 13)]
Change in mean 24-hour systolic blood pressure from baseline to end of treatment (Day 13).
- Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up [From end of treatment (Day 13) to end of follow-up (Day 18)]
Change in mean 24-hour systolic blood pressure from end of treatment (Day 13) to end of follow-up (Day 18).
- Change in Plasma Volume From Baseline to Start of Treatment [From baseline (Day 1) to start of treatment (Day 4)]
Change in plasma volume from baseline to start of treatment (Day 4).
- Change in Plasma Volume From Baseline to End of Treatment [From baseline (Day 1) to end of treatment (Day 14)]
Change in plasma volume from baseline to end of treatment (Day 14).
- Change in Plasma Volume From End of Treatment to End of Follow-up [From end of treatment (Day 14) to end of follow-up (Day 18)]
Change in plasma volume from end of treatment (Day 14) to end of follow-up (Day 18).
- Change in Extracellular Volume From Baseline to Start of Treatment [From baseline (Day 1) to start of treatment (Day 4)]
Change in extracellular volume from baseline to start of treatment (Day 4).
- Change in Extracellular Volume From Baseline to End of Treatment [From baseline (Day 1) to end of treatment (Day 14)]
Change in extracellular volume from baseline to end of treatment (Day 14).
- Change in Extracellular Volume From End of Treatment to End of Follow-up [From end of treatment (Day 14) to end of follow-up (Day 18)]
Change in extracellular volume from end of treatment (Day 14) to end of follow-up (Day 18).
- Change in 24-hour Urine Albumin:Creatinine Ratio (UACR) [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)]
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).
- Pharmacokinetics of Dapagliflozin on Day 4 and Day 14 [At pre-dose (Day 4) and at pre-dose, 1h, 2h, 4h post-dose (Day 14)]
Dapagliflozin plasma concentration on Day 4 (pre-dose) and Day 14 (pre-dose, 1h, 2h, 4h post-dose)
- Number of Patients With AEs and SAEs [From Day 1 until Day 18 (Follow-up)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Provision of signed and dated, written informed consent prior to any study specific procedures
-
Female and/or male aged between 18 years and ≤80 years
-
In the diabetic arms - a diagnosis of T2DM with HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol); and eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 or between >90 and ≤130 mL/min/1.73m2 for patients aged 59 years or younger, between >85 and ≤130 mL/min/1.73m2 for patients aged 60 to 69 years, and between >75 and ≤130 mL/min/1.73m2 for patients aged 70 years or older at the Screening Visit (Visit 1)
-
In the non-diabetic arm, HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit (Visit 1)
-
Patient specific optimal antihypertensive dose of an angiotensin receptor blocker at least 6 weeks before study treatment
-
In the diabetic arm (Group 2) an appropriate stable dose of metformin, or sulphonylurea, or metformin+sulphonylurea as anti-diabetic therapy for the last 12 weeks before study treatment
-
Stable urinary sodium excretion on 2 successive 24-hr urinary sodium excretion measurements.
-
In the diabetic arm with impaired renal function (Group 1), a stable insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) for the last 12 weeks prior to Visit 4 (Day 1), as judged by the Investigator. Metformin or sulphonylurea, or metformin+sulphonylurea together with insulin would be accepted, but is not mandatory. If used, stable dose of metformin or sulphonylurea, or metformin+sulphonylurea as anti-diabetic therapy for the last 12 weeks prior to Visit 4 (Day 1) is required.
Exclusion Criteria:
-
Diagnosis of Type 1 Diabetes Mellitus
-
Any of the following cardiovascular/vascular diseases within 3 months prior to signing the consent; myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable heart failure, heart failure NYHA Class IV, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia
-
Symptoms/complaints suggestive of established neurogenic bladder and/or incomplete bladder emptying
-
History of bladder cancer, diagnosis of polycystic kidney disease, history or current lupus nephritis or unstable or rapidly progressing renal disease
-
UACR >1000 mg/g at screening
-
Current/chronic use of the following medications: any anti-diabetic medication with the exception of metformin, sulphonylurea, angiotensin converting enzyme inhibitors, insulin (insulin only allowed in Group 1), oral glucocorticoids, non-steroidal anti-inflammatory drugs, immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants and monoamine oxidase inhibitors
-
Receiving immunosuppressive or other immunotherapy for primary or secondary renal disease within 6 months prior to screening
-
Current treatment or treatment within the last 2 weeks prior to screening with diuretics including loop diuretics, thiazides, and mineralocorticoid antagonists
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Almelo | Netherlands | 7609 PP | |
| 2 | Research Site | Amsterdam | Netherlands | 1081 HV | |
| 3 | Research Site | Stockholm | Sweden | 14186 | |
| 4 | Research Site | Örebro | Sweden | 70185 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT03152084
Other Study ID Numbers:
- D1690C00049
- 2016-002961-79
First Posted:
May 12, 2017
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 17 | 7 |
| COMPLETED | 17 | 7 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 2 | Group 3 | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 17 | 7 | 24 |
| Age, Customized (Number) [Number] | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 80 years |
17
100%
|
7
100%
|
24
100%
|
| >=80 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
35.3%
|
2
28.6%
|
8
33.3%
|
| Male |
11
64.7%
|
5
71.4%
|
16
66.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
5.9%
|
0
0%
|
1
4.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
16
94.1%
|
7
100%
|
23
95.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change in 24-hour Sodium Excretion From Baseline to Start of Treatment |
|---|---|
| Description | 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. |
| Time Frame | From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 6 |
| Median (Full Range) [mmol/24 hour] |
-5.33
|
-27.67
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.4462 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -5.21 | |
| Confidence Interval |
(2-Sided) 95% -19.542 to 9.120 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up |
|---|---|
| Description | 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). |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 6 |
| End of treatment vs baseline |
2.67
|
-23.83
|
| Follow-up vs end of treatment |
1.33
|
6.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.7842 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 3.69 | |
| Confidence Interval |
(2-Sided) 95% -24.817 to 32.195 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0581 |
| Comments | Follow-up vs End of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -16.72 | |
| Confidence Interval |
(2-Sided) 95% -34.109 to 0.664 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in 24-hour Glucose Excretion From Baseline to Start of Treatment |
|---|---|
| Description | Average change in 24-hour glucose excretion from average baseline values to average start of treatment values (Day 2 to 4). |
| Time Frame | From baseline (Day -3 to Day -1) to start of treatment (Day 2 to 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 5 |
| Median (Full Range) [mmol/24 hour] |
302.61
|
43.93
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 344.85 | |
| Confidence Interval |
(2-Sided) 95% 272.785 to 416.905 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in 24-hour Glucose Excretion From Baseline to End of Treatment |
|---|---|
| Description | Average change in 24-hour glucose excretion from average baseline values to average end of treatment values (Day 12 to 14) |
| Time Frame | From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 4 |
| Median (Full Range) [mmol/24 hour] |
283.40
|
29.88
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 311.30 | |
| Confidence Interval |
(2-Sided) 95% 224.528 to 398.064 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in 24-hour Glucose Excretion From End of Treatment to Follow-up |
|---|---|
| Description | 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). |
| Time Frame | From end of treatment (Day 12 to 14) to follow-up (Day 15 to 17) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 5 |
| Median (Full Range) [mmol/24 hour] |
-168.43
|
-37.02
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Follow-up vs end of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -203.07 | |
| Confidence Interval |
(2-Sided) 95% -235.983 to -170.162 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment |
|---|---|
| Description | Change in mean 24-hour systolic blood pressure from baseline to start of treatment (Day 4) |
| Time Frame | From baseline (Day -1) to start of treatment (Day 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 13 | 6 |
| Median (Full Range) [mmHg] |
-5.4810
|
-8.9730
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0047 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -5.2658 | |
| Confidence Interval |
(2-Sided) 95% -8.5459 to -1.9856 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment |
|---|---|
| Description | Change in mean 24-hour systolic blood pressure from baseline to end of treatment (Day 13). |
| Time Frame | From baseline (Day -1) to end of treatment (Day 13) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 12 | 6 |
| Median (Full Range) [mmHg] |
-5.9385
|
-10.3290
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -7.0987 | |
| Confidence Interval |
(2-Sided) 95% -10.0379 to -4.1595 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up |
|---|---|
| Description | Change in mean 24-hour systolic blood pressure from end of treatment (Day 13) to end of follow-up (Day 18). |
| Time Frame | From end of treatment (Day 13) to end of follow-up (Day 18) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 11 | 5 |
| Median (Full Range) [mmHg] |
2.5140
|
-2.6590
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.5592 |
| Comments | Follow-up vs end of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 0.7287 | |
| Confidence Interval |
(2-Sided) 95% -1.9894 to 3.4468 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Plasma Volume From Baseline to Start of Treatment |
|---|---|
| Description | Change in plasma volume from baseline to start of treatment (Day 4). |
| Time Frame | From baseline (Day 1) to start of treatment (Day 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 13 | 3 |
| Median (Full Range) [Litres] |
-0.1440
|
-0.1139
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.9288 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 0.0315 | |
| Confidence Interval |
(2-Sided) 95% -0.7274 to 0.7904 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Plasma Volume From Baseline to End of Treatment |
|---|---|
| Description | Change in plasma volume from baseline to end of treatment (Day 14). |
| Time Frame | From baseline (Day 1) to end of treatment (Day 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 11 | 1 |
| Median (Full Range) [Litres] |
-0.2122
|
2.0557
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.1659 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -0.4318 | |
| Confidence Interval |
(2-Sided) 95% -1.0761 to 0.2125 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Plasma Volume From End of Treatment to End of Follow-up |
|---|---|
| Description | Change in plasma volume from end of treatment (Day 14) to end of follow-up (Day 18). |
| Time Frame | From end of treatment (Day 14) to end of follow-up (Day 18) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 12 | 0 |
| Median (Full Range) [Litres] |
0.6464
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0190 |
| Comments | Follow-up vs end of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 0.4755 | |
| Confidence Interval |
(2-Sided) 95% 0.0963 to 0.8548 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Extracellular Volume From Baseline to Start of Treatment |
|---|---|
| Description | Change in extracellular volume from baseline to start of treatment (Day 4). |
| Time Frame | From baseline (Day 1) to start of treatment (Day 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 14 | 6 |
| Median (Full Range) [Litres] |
-0.5783
|
-0.4553
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0157 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -0.6713 | |
| Confidence Interval |
(2-Sided) 95% -1.1914 to -0.1511 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Extracellular Volume From Baseline to End of Treatment |
|---|---|
| Description | Change in extracellular volume from baseline to end of treatment (Day 14). |
| Time Frame | From baseline (Day 1) to end of treatment (Day 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 13 | 6 |
| Median (Full Range) [Litres] |
0.1248
|
-0.1427
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.8700 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -0.0324 | |
| Confidence Interval |
(2-Sided) 95% -0.4631 to 0.3984 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Extracellular Volume From End of Treatment to End of Follow-up |
|---|---|
| Description | Change in extracellular volume from end of treatment (Day 14) to end of follow-up (Day 18). |
| Time Frame | From end of treatment (Day 14) to end of follow-up (Day 18) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 13 | 6 |
| Median (Full Range) [Litres] |
0.1784
|
0.1394
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.2446 |
| Comments | Follow-up vs end of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 0.1718 | |
| Confidence Interval |
(2-Sided) 95% -0.1358 to 0.4795 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in 24-hour Urine Albumin:Creatinine Ratio (UACR) |
|---|---|
| Description | 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). |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 6 |
| Start of treatment vs baseline |
-0.07
|
-5.83
|
| End of treatment vs baseline |
-0.04
|
-7.28
|
| Follow-up vs end of treatment |
0.07
|
-0.19
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0023 |
| Comments | Start of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -2.10 | |
| Confidence Interval |
(2-Sided) 95% -3.299 to -0.902 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | End of treatment vs baseline | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | -1.59 | |
| Confidence Interval |
(2-Sided) 95% -1.929 to -1.256 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Within-group change | |
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | Follow-up vs end of treatment | |
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean |
| Estimated Value | 3.88 | |
| Confidence Interval |
(2-Sided) 95% 2.215 to 5.553 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Pharmacokinetics of Dapagliflozin on Day 4 and Day 14 |
|---|---|
| Description | Dapagliflozin plasma concentration on Day 4 (pre-dose) and Day 14 (pre-dose, 1h, 2h, 4h post-dose) |
| Time Frame | At pre-dose (Day 4) and at pre-dose, 1h, 2h, 4h post-dose (Day 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 17 | 7 |
| Day 4, Pre-dose |
4.58
(134.88)
|
19.78
(116.54)
|
| Day 14, Pre-dose |
4.54
(46.60)
|
15.26
(41.97)
|
| Day 14, 1 h |
57.46
(110.66)
|
63.83
(150.41)
|
| Day 14, 2 h |
46.47
(49.30)
|
60.41
(140.69)
|
| Day 14, 4 h |
29.71
(47.38)
|
47.83
(100.41)
|
| Title | Number of Patients With AEs and SAEs |
|---|---|
| Description | 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. |
| Time Frame | From Day 1 until Day 18 (Follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 2 | Group 3 |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 17 | 7 |
| Any AE |
6
|
2
|
| AEs judged as causally related to dapagliflozin |
4
|
0
|
| AEs leading to death |
0
|
0
|
| SAEs (including outcomes = death) |
0
|
0
|
| SAEs causally related to dapagliflozin |
0
|
0
|
| AEs leading to permanent discontinuation of dapagliflozin |
0
|
0
|
| SAEs leading to permanent discontinuation of dapagliflozin |
0
|
0
|
| Hypoglycaemia AEs |
0
|
0
|
| Hypoglycaemia AEs leading to permanent discontinuation of dapagliflozin |
0
|
0
|
Adverse Events
| Time Frame | Day 1 until Day 18 (FU) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Group 2 | Group 3 | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Group 2 | Group 3 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/7 (0%) | ||
Serious Adverse Events |
||||
| Group 2 | Group 3 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Group 2 | Group 3 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/17 (35.3%) | 2/7 (28.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/17 (0%) | 0 | 1/7 (14.3%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Nausea | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| General disorders | ||||
| Fatigue | 1/17 (5.9%) | 2 | 0/7 (0%) | 0 |
| Infections and infestations | ||||
| Genital infection | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Influenza | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 0/17 (0%) | 0 | 1/7 (14.3%) | 1 |
| Nervous system disorders | ||||
| Head discomfort | 2/17 (11.8%) | 2 | 0/7 (0%) | 0 |
| Somnolence | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Dry skin | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Pruritus | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
| Vascular disorders | ||||
| Haematoma | 1/17 (5.9%) | 1 | 0/7 (0%) | 0 |
Limitations/Caveats
The study was prematurely closed due to unsatisfactory recruitment rate. Of 5 patients enrolled in the Group 1, none were enrolled into the Run-in set due to failure to meet inclusion/exclusion criteria, screen failure, withdrawal or other reason and hence it was decided that no more Group 1 patients would be enrolled in the study. In Group 2 and 3, 17 and 7 patients received the investigational product and completed the study, respectively.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Study results are Sponsor's intellectual property and PIs cannot present or publish results without prior Sponsor approval.
Results Point of Contact
| Name/Title | Global Clinical Lead |
|---|---|
| Organization | AstraZeneca Clinical Study Information Center |
| Phone | 1-877-240-9479 |
| information.center@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT03152084
Other Study ID Numbers:
- D1690C00049
- 2016-002961-79
First Posted:
May 12, 2017
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021