Diabetes Mellitus, Type 2Phase 4NCT04620590
Dapagliflozin Treatment in Type 2 Diabetes
A Phase 4 study testing Dapagliflozin 10 MG [Farxiga] in people with Diabetes Mellitus, Type 2 and Impaired Renal Function, run by Emerald Clinical Inc. at 2 sites in 2 countries.
Trial summary
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Impaired Renal Function
- What is being tested?
- Dapagliflozin 10 MG [Farxiga]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Apr 2021to 30 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 less than or equal to 80 years.
- A diagnosis of T2DM with HbA1c ≥6.5% (≥48 mmol/mol) and =11% (<97 mmol/mol); and eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2.
- Patient specific optimal antihypertensive dose of an ACEi or ARB (as per Investigator's judgement) for at least 6 weeks prior to Visit 4 (Day 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, sulphonylurea, DPP4 inhibitors or any combinations of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylurea, or DPP4 inhibitors or their combination as anti-diabetic therapy for the last 12 weeks prior to start of treatment with dapagliflozin is required.
- Suitable veins for cannulation or repeated venipuncture.
Show all 9Show fewer
- Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- Patient specific optimal antihypertensive dose of an ACEi or ARB (as per Investigator's judgement) for at least 6 weeks prior to Visit 4 (Day 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, sulphonylurea, DPP4 inhibitors or any combination of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylurea, or DPP4 inhibitors or their combination as anti-diabetic therapy for the last 12 weeks prior to start of treatment with dapagliflozin is required.
Who cannot join
- Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 6 months prior to Screening Visit (Visit 1).
- Involvement in the planning and conduct of the study (applies to both UMCG staff and staff at third party vendor or at investigational sites).
- Hypersensitivity to dapaglifozin, indocyanine green, sodium iodide, or iodine, or patients who have poorly tolerated indocyanine green in the past.
- Pacemaker or other implanted electronic devices.
- Pregnancy.
- Breastfeeding.
Show all 22Show fewer
- Known clinically significant disease or disorder; or clinically relevant abnormal findings in physical examination, clinical chemistry, haematology and urinalysis; or unstable or rapidly progressing renal disease; other dietary restrictions that would make it difficult for the subject to follow the protocol required diet plan or any other condition or minor medical complaint, which, in the opinion of the investigator, may either put the patient atrisk because of participation in the study, or influence the results, or the patient's ability to participate in the study and comply with study procedures, restrictions and requirements.
- Diagnosis of T1DM.
- Hyperthyroidism or autonomic thyroid adenomas.
- Abnormal vital signs, after 10 minutes supine rest, defined as any opf the following (Visit 1); Systolic blood pressure above 180mmHg; Diastolic blood pressure above 110 mmHg; Pulse less than 50 bpm or greater than 100 bpm.
- Any of the following cardiovascular/vascular within 3 months prior to signing the consent at Visit 1, as assessed by the Investigator: myocardial infarction, cardiac surgery or revascularization (coronary artery bypass graft [CABG]/ percutaneous transluminal coronary angioplasty [PTCA], unstable angina, unstable heart failure, heart failure New York Association Class IV, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
- Patients with severe hepatic impairment (Child-Pugh C).
- Ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents, unless the diet or treatment has been stopped at least 3 months before Screening Visit, ensuring patients having a stable body weight with no verified body weight variability of greater then 3 kg during the 3 months before Screening Visit.
- Symptoms/complaints suggestive of established neurogenic bladder and/or incomplete bladder emptying.
- History of bladder cancer.
- Non-diabetic kidney disease.
- UACR greater than 1000 mg/g per day at the Screening Visit based on spot urine sample (quantitative assessment).
- Current chronic use of the following medication: glucagon-like peptide receptor agonists or thiazolidinediones, oral glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors.
- Receiving immunosuppressive or other immunotherapy for primary or secondary renal disease within 6 months prior to Screening Visit (Visit 1).
- Current treatment or treatment within the last 2 weeks prior to Screening Visit (Visit 1) with mineralocorticoid antagonists (loop or thiazide diuretics are allowed as long as they are used in stable dose for at least 4 weeks prior to screening).
- A metformin dose which is outside the specified dose range for renal impairment according to local guidelines and/or Investigator's judgement.
- Medicinal products and substances that can reduce or increase absorption of indocyanine green; anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone (reduced absorption), and cyclopropane, probenecid, rifamycin (increased absorption).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
CU Anschutz Medical Campus - Clinical Translational Research Center (CTRC)
Aurora, Colorado, 80045
About this study
Official title: DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. The study will allow for an up to 6-week Screening and Run-in Period, a 2-week Treatment Period and a 5-day Follow-up Period. Patients will consume food from standardized food boxes starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
Read the detailed description
This is an open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. The study population is as described below. The maximum duration of the study will be 62 days including the allowed window periods for the study (±1 day for Visit 7 at Day 13). The study will allow for an up to 6-week Screening and Run-in Period. The Run-in Period should always last 6 days for patients not on insulin but may be up to 20 days (day -20 to day -1) for patients on insulin. Patients on insulin may require a longer Run-in Period in order to be able to adjust their insulin requirements according to the caloric content of the food boxes, if needed. It is recommended to keep the insulin dose stable during the trial, but investigators can change the dose if medically required. However, it is not mandatory for the patient on insulin to use the entire extended Run-in Period. Based on the Investigator's judgement, the Run-in Period may be shortened once each patient (on insulin) has had sufficient time to adapt to the food boxes, and it is determined that the patient's insulin requirement has stabilised sufficiently to continue in the study. The study will then include a 2-week Treatment Period (Day 1 to Day 14) and a 5-day Follow-up Period: Day 15 to Day 19. Patients will consume food from standardised food boxes (with sodium content 150 mmol) starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
- Conditions
- Diabetes Mellitus, Type 2, Impaired Renal Function
- Being tested
- Dapagliflozin 10 MG [Farxiga]
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG [Farxiga]Drug
Dapagliflozin is a stable, reversible, highly selective, and orally active inhibitor of human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for glucose reabsorption in the kidney. Patients will receive one tablet dapagliflozin 10 mg per day for a total period of 14±1 days. This dose is the recommended dose for monotherapy and for add-on combination therapy with other glucose-lowering medicinal products including insulin to improve glycaemic control in T2DM.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days. Receives: Drug: Dapagliflozin 10 MG [Farxiga] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hr sodium excretion
To investigate change in 24-hr sodium excretion during dapagliflozin treatment between Baseline (average of Days -3 to -1) and average of Days 2 to 4 within each study group in patients with type 2 diabetes mellitus (T2DM) with impaired renal function.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start20 Apr 2021
- Primary completion30 May 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emerald Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen, Ground Zero Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Hiddo JL Heerspink, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620590
- Sponsor's protocol ID
- UMCG 20-001
- Other IDs
- 2020-001247-12, HC6-24-c243179
- Status last verified
- Apr 2023
- First submitted
- 3 Nov 2020
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT04620590
- Acronym / sponsor ID
- UMCG 20-001
- Conditions
- Diabetes Mellitus, Type 2, Impaired Renal Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Emerald Clinical Inc.Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen, Ground Zero Pharmaceuticals
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. The study will allow for an up to 6-week Screening and Run-in Period, a 2-week Treatment Period and a 5-day Follow-up Period. Patients will consume food from standardized food boxes starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
Detailed description
This is an open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. The study population is as described below. The maximum duration of the study will be 62 days including the allowed window periods for the study (±1 day for Visit 7 at Day 13). The study will allow for an up to 6-week Screening and Run-in Period. The Run-in Period should always last 6 days for patients not on insulin but may be up to 20 days (day -20 to day -1) for patients on insulin. Patients on insulin may require a longer Run-in Period in order to be able to adjust their insulin requirements according to the caloric content of the food boxes, if needed. It is recommended to keep the insulin dose stable during the trial, but investigators can change the dose if medically required. However, it is not mandatory for the patient on insulin to use the entire extended Run-in Period. Based on the Investigator's judgement, the Run-in Period may be shortened once each patient (on insulin) has had sufficient time to adapt to the food boxes, and it is determined that the patient's insulin requirement has stabilised sufficiently to continue in the study. The study will then include a 2-week Treatment Period (Day 1 to Day 14) and a 5-day Follow-up Period: Day 15 to Day 19. Patients will consume food from standardised food boxes (with sodium content 150 mmol) starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Dapagliflozin 10 MG [Farxiga]Patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Female and/or male aged between 18 years and less than or equal to 80 years.
- A diagnosis of T2DM with HbA1c ≥6.5% (≥48 mmol/mol) and =11% (<97 mmol/mol); and eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2.
- Patient specific optimal antihypertensive dose of an ACEi or ARB (as per Investigator's judgement) for at least 6 weeks prior to Visit 4 (Day 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, sulphonylurea, DPP4 inhibitors or any combinations of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylurea, or DPP4 inhibitors or their combination as anti-diabetic therapy for the last 12 weeks prior to start of treatment with dapagliflozin is required.
Key exclusion criteria (22 listed)
- Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 6 months prior to Screening Visit (Visit 1).
- Involvement in the planning and conduct of the study (applies to both UMCG staff and staff at third party vendor or at investigational sites).
- Hypersensitivity to dapaglifozin, indocyanine green, sodium iodide, or iodine, or patients who have poorly tolerated indocyanine green in the past.
- Pacemaker or other implanted electronic devices.
- Pregnancy.
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 |
|---|---|---|
| Dapagliflozin 10 MG [Farxiga]Dapagliflozin is a stable, reversible, highly selective, and orally active inhibitor of human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for glucose reabsorption in the kidney. Patients will receive one tablet dapagliflozin 10 mg per day for a total period of 14±1 days. This dose is the recommended dose for monotherapy and for add-on combination therapy with other glucose-lowering medicinal products including insulin to improve glycaemic control in T2DM. | Drug | Treatment Arm |
Primary outcome
Change in 24-hr sodium excretion
Time frame: 24 hours
To investigate change in 24-hr sodium excretion during dapagliflozin treatment between Baseline (average of Days -3 to -1) and average of Days 2 to 4 within each study group in patients with type 2 diabetes mellitus (T2DM) with impaired renal function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Hiddo JL Heerspink principal investigator
Investigator
2 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 10 MG [Farxiga] in people with Diabetes Mellitus, Type 2 and Impaired Renal Function, run by Emerald Clinical Inc. at 2 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-hr sodium excretion (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2025.