Diabetes Mellitus, Type 2Phase 4DAPASALTNCT03152084

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.

A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Kidney Function Tests, run by AstraZeneca at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2, Kidney Function Tests
What is being tested?: Dapagliflozin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 4 sitesin 2 countries
Study dates: 12 Jul 2017to 20 Mar 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Netherlands2 sites

Research Site
Almelo, 7609 PP
Research Site
Amsterdam, 1081 HV

Other trials in Netherlands

Sweden2 sites

Research Site
Örebro, 70185
Research Site
Stockholm, 14186

Other trials in Sweden

About this study

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

The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function

Conditions: Diabetes Mellitus, Type 2, Kidney Function Tests
Being tested: Dapagliflozin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.

Study groups in NCT03152084
Study group	Role	What they receive
Arm 1	Experimental	T2DM subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. Receives: Drug: Dapagliflozin
Arm 2	Experimental	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. Receives: Drug: Dapagliflozin
Arm 3	Experimental	Non-diabetic subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit. Receives: Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 24-hour Sodium Excretion From Baseline to Start of Treatment
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.
Measured: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4)

Secondary outcomes (16)

Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up
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).
Measured: 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)
Change in 24-hour Glucose Excretion From Baseline to Start of Treatment
Average change in 24-hour glucose excretion from average baseline values to average start of treatment values (Day 2 to 4).
Measured: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to 4)
Change in 24-hour Glucose Excretion From Baseline to End of Treatment
Average change in 24-hour glucose excretion from average baseline values to average end of treatment values (Day 12 to 14)
Measured: From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14)
Change in 24-hour Glucose Excretion From End of Treatment to Follow-up
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).
Measured: From end of treatment (Day 12 to 14) to follow-up (Day 15 to 17)
Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment
Change in mean 24-hour systolic blood pressure from baseline to start of treatment (Day 4)
Measured: From baseline (Day -1) to start of treatment (Day 4)
Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment
Change in mean 24-hour systolic blood pressure from baseline to end of treatment (Day 13).
Measured: From baseline (Day -1) to end of treatment (Day 13)
Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up
Change in mean 24-hour systolic blood pressure from end of treatment (Day 13) to end of follow-up (Day 18).
Measured: From end of treatment (Day 13) to end of follow-up (Day 18)
Change in Plasma Volume From Baseline to Start of Treatment
Change in plasma volume from baseline to start of treatment (Day 4).
Measured: From baseline (Day 1) to start of treatment (Day 4)
Change in Plasma Volume From Baseline to End of Treatment
Change in plasma volume from baseline to end of treatment (Day 14).
Measured: From baseline (Day 1) to end of treatment (Day 14)
Change in Plasma Volume From End of Treatment to End of Follow-up
Change in plasma volume from end of treatment (Day 14) to end of follow-up (Day 18).
Measured: From end of treatment (Day 14) to end of follow-up (Day 18)
Change in Extracellular Volume From Baseline to Start of Treatment
Change in extracellular volume from baseline to start of treatment (Day 4).
Measured: From baseline (Day 1) to start of treatment (Day 4)
Change in Extracellular Volume From Baseline to End of Treatment
Change in extracellular volume from baseline to end of treatment (Day 14).
Measured: From baseline (Day 1) to end of treatment (Day 14)
Change in Extracellular Volume From End of Treatment to End of Follow-up
Change in extracellular volume from end of treatment (Day 14) to end of follow-up (Day 18).
Measured: From end of treatment (Day 14) to end of follow-up (Day 18)
Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
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).
Measured: 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)
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Dapagliflozin plasma concentration on Day 4 (pre-dose) and Day 14 (pre-dose, 1h, 2h, 4h post-dose)
Measured: At pre-dose (Day 4) and at pre-dose, 1h, 2h, 4h post-dose (Day 14)
Number of Patients With AEs and SAEs
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.
Measured: From Day 1 until Day 18 (Follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 201720 Mar 2020

First posted12 May 2017
Study start12 Jul 2017
Primary completion20 Mar 2020
Study completion20 Mar 2020

Why it stopped: Poor recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03152084
Sponsor's protocol ID: D1690C00049
Other IDs: 2016-002961-79, 2016
Acronym: DAPASALT
Status last verified: May 2021
First submitted: 18 Apr 2017
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Hammarstedt A, Karlsson C, Hallow KM, Danser AHJ, Heerspink HJL, van Raalte DH. The Adaptive Renal Response for Volume Homeostasis During 2 Weeks of Dapagliflozin Treatment in People With Type 2 Diabetes and Preserved Renal Function on a Sodium-Controlled Diet. Kidney Int Rep. 2022 Mar 4;7(5):1084-1092. doi: 10.1016/j.ekir.2022.02.023. eCollection 2022 May.
PubMed 35570989
Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Karlsson C, Hammarstedt A, Arya N, van Raalte DH, Heerspink HJL. Natriuretic Effect of Two Weeks of Dapagliflozin Treatment in Patients With Type 2 Diabetes and Preserved Kidney Function During Standardized Sodium Intake: Results of the DAPASALT Trial. Diabetes Care. 2021 Feb;44(2):440-447. doi: 10.2337/dc20-2604. Epub 2020 Dec 14.
PubMed 33318125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03152084
Acronym / sponsor ID: DAPASALT / D1690C00049
Conditions: Diabetes Mellitus, Type 2, Kidney Function Tests
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor recruitment.
Enrolment: 24 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 12 Jul 2017 (actual)
Primary completion: 20 Mar 2020 (actual)
Study completion: 20 Mar 2020 (actual)
First posted: 12 May 2017 (actual)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Drug: DapagliflozinT2DM subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit.
Arm 2	Experimental	Drug: DapagliflozinT2DM 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.
Arm 3	Experimental	Drug: DapagliflozinNon-diabetic subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinThe study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.	Drug	Arm 1, Arm 2, Arm 3

Primary outcome

Change in 24-hour Sodium Excretion From Baseline to Start of Treatment
Time frame: 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.

16 secondary outcomes

Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up
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)
Change in 24-hour Glucose Excretion From Baseline to Start of Treatment
Time frame: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to 4)
Change in 24-hour Glucose Excretion From Baseline to End of Treatment
Time frame: From baseline (Day -3 to Day -1) to end of treatment (Day 12 to 14)
Change in 24-hour Glucose Excretion From End of Treatment to Follow-up
Time frame: From end of treatment (Day 12 to 14) to follow-up (Day 15 to 17)
Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment
Time frame: From baseline (Day -1) to start of treatment (Day 4)
Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment
Time frame: From baseline (Day -1) to end of treatment (Day 13)
Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up
Time frame: From end of treatment (Day 13) to end of follow-up (Day 18)
Change in Plasma Volume From Baseline to Start of Treatment
Time frame: From baseline (Day 1) to start of treatment (Day 4)
Change in Plasma Volume From Baseline to End of Treatment
Time frame: From baseline (Day 1) to end of treatment (Day 14)
Change in Plasma Volume From End of Treatment to End of Follow-up
Time frame: From end of treatment (Day 14) to end of follow-up (Day 18)
Change in Extracellular Volume From Baseline to Start of Treatment
Time frame: From baseline (Day 1) to start of treatment (Day 4)
Change in Extracellular Volume From Baseline to End of Treatment
Time frame: From baseline (Day 1) to end of treatment (Day 14)
Change in Extracellular Volume From End of Treatment to End of Follow-up
Time frame: From end of treatment (Day 14) to end of follow-up (Day 18)
Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
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)
Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
Time frame: At pre-dose (Day 4) and at pre-dose, 1h, 2h, 4h post-dose (Day 14)
Number of Patients With AEs and SAEs
Time frame: From Day 1 until Day 18 (Follow-up)

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 2	17	17
Group 3	7	7

Primary outcome: Change in 24-hour Sodium Excretion From Baseline to Start of Treatment

Time frame: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4). Median (Full Range). Unit: mmol/24 hour

Measure	Group 2 n = 15	Group 3 n = 6
Value	-5.33 (-53.667 to 44.000)	-27.67 (-69.334 to 13.334)

Group 2: Least square mean: -5.21 (95% CI -19.542 to 9.120), p = 0.4462, Mixed Models Analysis

Population analysed: 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.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 until Day 18 (FU). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 2	0 of 17 (0%)	6 of 17 (35.3%)	0 of 17
Group 3	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35570989Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Hammarstedt A, Karlsson C, Hallow KM, Danser AHJ, Heerspink HJL, van Raalte DH. The Adaptive Renal Response for Volume Homeostasis During 2 Weeks of Dapagliflozin Treatment in People With Type 2 Diabetes and Preserved Renal Function on a Sodium-Controlled Diet. Kidney Int Rep. 2022 Mar 4;7(5):1084-1092. doi: 10.1016/j.ekir.2022.02.023. eCollection 2022 May.
Derived from this study: PubMed 33318125Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Karlsson C, Hammarstedt A, Arya N, van Raalte DH, Heerspink HJL. Natriuretic Effect of Two Weeks of Dapagliflozin Treatment in Patients With Type 2 Diabetes and Preserved Kidney Function During Standardized Sodium Intake: Results of the DAPASALT Trial. Diabetes Care. 2021 Feb;44(2):440-447. doi: 10.2337/dc20-2604. Epub 2020 Dec 14.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Kidney Function Tests, run by AstraZeneca at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour Sodium Excretion From Baseline to Start of Treatment (time frame: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152084, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.