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Diabetic Kidney DiseasePhase 4LIRALBUNCT02545738

Antiproteinuric Effects of Liraglutide Treatment

A Phase 4 study testing Liraglutide in people with Diabetic Kidney Disease, run by Steno Diabetes Center Copenhagen 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

The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
Liraglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteDenmark
Study dates
Apr 2015to May 2016
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

  • Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
  • Male or female patients >18 years with type 2 diabetes (WHO criteria).
  • HbA1c ≥ 48 mmol/mol (6.5 %)
  • eGFR ≥ 30 ml/min/1.73 m2 (estimated by MDRD formula)
  • Fertile female patients must use chemical, hormonal or mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
  • Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion)
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  • Geometic mean urine albumin-to-creatinine ratio (UACR) above 30 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)
  • Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening.
  • Patients must be on stable glucose lowering medication for at least two weeks before the first visit.
  • Must be able to communicate with the investigator.

Who cannot join

  • SBP > 180 mm Hg at screening
  • Type 1 diabetes mellitus
  • Chronic pancreatitis / previous acute pancreatitis
  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, which in the investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
  • Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
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  • Inflammatory bowel disease
  • Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
  • Previous bowel resection
  • Body mass index <18.5 kg/m2
  • Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods
  • Clinical signs of diabetic gastroparesis
  • Impaired liver function (transaminases > two times upper reference levels)
  • The receipt of any investigational product 90 days prior to this trial
  • Known or suspected abuse of alcohol or narcotics
  • Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Peter Rossing

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial

The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.

Read the detailed description

Initial findings point to a clinically significant antiproteinuric effect of liraglutide treatment, possibly independent from blood pressure reduction. The mechanism behind is unclear and the magnitude of albuminuria reduction needs to be verified. Antiproteinuric effects are usually renoprotective and potentially also cardioprotective and may suggest an additional benefit from liraglutide treatment.

The aim of this study is to evaluate the magnitude of the antiproteinuric effect of short-term liraglutide treatment (12 weeks) in patients with type 2 diabetes and albuminuria. In addition, possible mechanisms causing the antiproteinuric effect will be explored.

Being tested
Liraglutide, placebo
Medical subject headings
Diabetic Nephropathies

What participants receive

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

  • LiraglutideDrug

    Also called Victoza

    active treatment

  • placeboDrug

    placebo

Study groups in NCT02545738
Study groupRoleWhat they receive
LiraglutideExperimentalLiraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorPlacebo s.c. for 12 weeks.
Receives: Drug: placebo

What is being measured

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

  1. Change in albuminuria

    24h urinary albumin excretion rate (UAER mg/24h)

    Measured: 24 weeks

Secondary outcomes (5)

  1. Change in renin-angiotensin system hormones

    renin (activity and concentration), angiotensin 1+2, aldosteron (concentrations)

    Measured: 24 weeks

  2. Change in kidney function

    Cr-EDTA-GFR (ml/min/1.73m2)

    Measured: 24 weeks

  3. Change in 24h blood pressure

    24 h systolic and diastolic blood presure (mmHg)

    Measured: 24 weeks

  4. Change in markers of inflammation

    TNF-alfa, mcp (concentration)

    Measured: 24 weeks

  5. 24h heart rate

    puls in BPM

    Measured: 24 weeks

Timeline

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

  1. First posted10 Sep 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545738
Sponsor's protocol ID
2014-004502-15
Other IDs
2014
Acronym
LIRALBU
Status last verified
Aug 2016
First submitted
13 Apr 2015
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • 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

  • Wretlind A, Curovic VR, de Zawadzki A, Suvitaival T, Xu J, Zobel EH, von Scholten BJ, Ripa RS, Kjaer A, Hansen TW, Vilsboll T, Vestergaard H, Rossing P, Legido-Quigley C. Ceramides are decreased after liraglutide treatment in people with type 2 diabetes: a post hoc analysis of two randomized clinical trials. Lipids Health Dis. 2023 Sep 26;22(1):160. doi: 10.1186/s12944-023-01922-z.

    PubMed 37752566

  • von Scholten BJ, Persson F, Rosenlund S, Hovind P, Faber J, Hansen TW, Rossing P. The effect of liraglutide on renal function: A randomized clinical trial. Diabetes Obes Metab. 2017 Feb;19(2):239-247. doi: 10.1111/dom.12808. Epub 2016 Nov 21.

    PubMed 27753201

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Diabetic Kidney Disease, run by Steno Diabetes Center Copenhagen 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 10 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 Aug 2016. 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 albuminuria (time frame: 24 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 NCT02545738, which also lists 4 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 Aug 2016.

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