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Type 2 DiabetesPhase 4DapKidNCT02914691

Effects of Dapagliflozin Treatment on Urinary Proteomic Patterns in Patients With Type 2 Diabetes

A Phase 4 study testing Dapagliflozine 10 mg once daily tablet treatment in people with Type 2 Diabetes and Diabetic Nephropathy, run by Peter Rossing at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A part from reducing blood glucose, systemic blood pressure and albuminuria are decreased, while natriuresis is increased. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Diabetic Nephropathy
What is being tested?
Dapagliflozine 10 mg once daily tablet treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteDenmark
Study dates
Aug 2015to 5 Jul 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients >18 years of age with a diagnosis of type 2 diabetes (WHO criteria).
  • Patients must be on current stable antiglycaemic treatment with oral drugs (OAD) or insulin 4 weeks before start of study drug and throughout study duration.
  • Patients must be on stable antihypertensive treatment (must include renin-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration.
  • HbA1c >7.5 %
  • Urinary albumin creatinine ratio (UACR) > 30 mg/g (in ≥2 out 3 morning spot urine collections prior to randomisation).
  • eGFR ≥ 45 ml/min/1.73 m2
  • Stable RAAS-blocking treatment (more than or equal to 4 weeks prior to visit 0) If not stable at visit 0, screening phase can be prolonged to 4 weeks.

Who cannot join

  • Current treatment with loop diuretics
  • Current treatment with thiazolidinediones
  • Current treatment with dapagliflozin or other SGLT2 inhibitor
  • Ongoing cancer treatment
  • Patients on hypertension treatment who are is not on stable antihypertensive treatment (must include renin-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration
  • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
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  • Total bilirubin >2.0 mg/dL (34.2 µmol/L)
  • Positive serologic evidence of current infectious liver disease including, Hepatitis B surface antigen and antibody and Hepatitis C virus antibody
  • eGFR: <45 mL/min (calculated by MDRD formula)
  • History of unstable or rapidly progressing renal disease
  • Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
  • Recent Cardiovascular Events in a patient:
  • 1. Acute Coronary Syndrome (ACS) within 2 months prior to enrolment 2.Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment 3. Acute Stroke or TIA within two months prior to enrolment 4. Less than two months post coronary artery revascularization
  • Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study.
  • Pregnant or breastfeeding patients
  • Patients who, in the judgement of the investigator, may be at risk for dehydration

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A part from reducing blood glucose, systemic blood pressure and albuminuria are decreased, while natriuresis is increased.

Previous research into urinary peptide patterns (proteomics) has revealed that patients in risk of progressive renal disease display a "risk peptide pattern" in their urine, ahead of decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk.

Read more

The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but long term randomized trials are ongoing. By investigating the impact of dapa treatment on this peptide pattern, it will be determined whether this intervention can improve the urinary proteomic peptide pattern. In addition new knowledge regarding renal processes that the treatment influences is sought.

The impact of treatment of urinary and tubular markers of oxidative stress and function (metabolomics) will be assessed. These markers are thought to represent one of several deleterious pathways involved in the pathology of diabetic renal disease, and here the impact dapa treatment will be investigated. Improvement of these markers of oxidative stress may indicate long-term benefit.

Objective: The primary objective is to assess the impact of three months of treatment with dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of diabetic comorbidity.

Design: Double blinded, randomized, placebo-controlled crossover, single center study. Treatment period: 2 x 12 weeks.

Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in accordance with the study in- and exclusion criteria.

Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes, microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2.

Secondary endpoints are the effect of the intervention on other markers for tubular function, inflammation, endothelial dysfunction, microcirculation, kidney function, albuminuria, vasoactive hormones in plasma, and effect on global longitudinal strain as measured by echocardiography.

Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last patient is expected to be completed October 2016. Data analysis completed December 2016, presentation autumn 2017 and publication early 2018.

Being tested
Dapagliflozine 10 mg once daily tablet treatment, Placebo identical once daily tablet treatment
Keywords
Type 2 diabetes, Diabetic Nephropathy, Proteomics, Albuminuria, SGLT2 inhibitor
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Albuminuria

What participants receive

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

  • Dapagliflozine 10 mg once daily tablet treatmentDrug

  • Placebo identical once daily tablet treatmentDrug

Study groups in NCT02914691
Study groupRoleWhat they receive
ActiveActive comparatorDapagliflozin 10 mg once daily tablet treatment
Receives: Drug: Dapagliflozine 10 mg once daily tablet treatment
PlaceboPlacebo comparatorIdentical once daily tablet treatment
Receives: Drug: Placebo identical once daily tablet treatment

What is being measured

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

  1. Change in Urinary Peptide Patterns (Proteomics)

    Proteomics will be evaluated at week 0, at crossover week 12 (+/- 1 week), and at end study week 24 (+/- 1 week)

    Measured: Up to 26 weeks

Timeline

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

  1. First posted26 Sep 2016 (estimated)
  2. Study startAug 2015
  3. Primary completion5 Jul 2017
  4. Study completion5 Jul 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914691
Sponsor's protocol ID
2015-000335-32
Other IDs
2015
Acronym
DapKid
Status last verified
Sep 2018
First submitted
9 Sep 2016
Last updated
10 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Iversen E, Nielsen LJ, Curovic VR, Walls AB, Eickhoff MK, Frimodt-Moller M, Persson F, Rossing P, Houlind MB. Effect of Dapagliflozin on Measured vs. Panel-Estimated Glomerular Filtration Rate. Clin Pharmacol Ther. 2025 Feb;117(2):515-522. doi: 10.1002/cpt.3480. Epub 2024 Oct 21.

    PubMed 39434255

  • Iversen E, Christensen KM, Walls AB, Eickhoff MK, von Scholten BJ, Frimodt-Moller M, Hansen TW, Persson F, Rossing P, Rotbain Curovic V, Houlind MB. Performance of new and panel CKD-EPI equations in European adults with type 2 diabetes. Diabetes Obes Metab. 2024 Jun;26(6):2501-2504. doi: 10.1111/dom.15536. Epub 2024 Mar 6. No abstract available.

    PubMed 38449081

  • Larsen EL, Andersen A, Kjaer LK, Eickhoff MK, Frimodt-Moller M, Persson F, Rossing P, Lykkesfeldt J, Knop FK, Vilsboll T, Rungby J, Poulsen HE. Effects of two- and twelve-weeks sodium-glucose cotransporter 2 inhibition on DNA and RNA oxidation: two randomized, placebo-controlled trials. Free Radic Res. 2023 Feb;57(2):140-151. doi: 10.1080/10715762.2023.2213820. Epub 2023 May 19.

    PubMed 37171199

  • Curovic VR, Eickhoff MK, Ronkko T, Frimodt-Moller M, Hansen TW, Mischak H, Rossing P, Ahluwalia TS, Persson F. Dapagliflozin Improves the Urinary Proteomic Kidney-Risk Classifier CKD273 in Type 2 Diabetes with Albuminuria: A Randomized Clinical Trial. Diabetes Care. 2022 Nov 1;45(11):2662-2668. doi: 10.2337/dc22-1157.

    PubMed 35998283

  • Eickhoff MK, Olsen FJ, Frimodt-Moller M, Diaz LJ, Faber J, Jensen MT, Rossing P, Persson F. Effect of dapagliflozin on cardiac function in people with type 2 diabetes and albuminuria - A double blind randomized placebo-controlled crossover trial. J Diabetes Complications. 2020 Jul;34(7):107590. doi: 10.1016/j.jdiacomp.2020.107590. Epub 2020 Apr 18.

    PubMed 32340841

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozine 10 mg once daily tablet treatment in people with Type 2 Diabetes and Diabetic Nephropathy, run by Peter Rossing at 1 site in Denmark.

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 7 inclusion and 16 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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 Urinary Peptide Patterns (Proteomics) (time frame: Up to 26 weeks). 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 NCT02914691, which also lists 5 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 10 Sep 2018.

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