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Trial · Interventional

CompletedPhase 4Registry data

Antiproteinuric Effects of Liraglutide Treatment

Short name LIRALBU

NCTNCT02545738 (opens ClinicalTrials.gov in a new tab)Other id2014-004502-15Other id2014

Overview

Status
Completed
Phase
Phase 4
Enrollment
32 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Apr 2015
Primary completion
May 2016
Completion
May 2016
First posted
10 Sept 2015 (estimated)
Last update posted
10 Aug 2016 (estimated)
Conditions
Diabetic Kidney Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 4

    LIRALBU

    NCT02545738

    Apr 2015 to May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • LiraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.

  • Placebo comparator

    Placebo

    Placebo s.c. for 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in albuminuria

    Time frame · 24 weeks

    Registry description

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

Secondary outcomes(5)
  1. Change in renin-angiotensin system hormones

    Time frame · 24 weeks

    Registry description

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

  2. Change in kidney function

    Time frame · 24 weeks

    Registry description

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

  3. Change in 24h blood pressure

    Time frame · 24 weeks

    Registry description

    24 h systolic and diastolic blood presure (mmHg)

  4. Change in markers of inflammation

    Time frame · 24 weeks

    Registry description

    TNF-alfa, mcp (concentration)

  5. 24h heart rate

    Time frame · 24 weeks

    Registry description

    puls in BPM

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Indexing hint: Randomized controlled trial · 2017

9 results

The effect of liraglutide on renal function: A randomized clinical trial.

von Scholten et al. 2017Diabetes, obesity & metabolismcited by 86

PMID 27753201DOI 10.1111/dom.12808PUB-27753201

Full text at the publisher9 results

More studies

1 study on this page

PubMed tag: none · 2023

Ceramides are decreased after liraglutide treatment in people with type 2 diabetes: a post hoc analysis of two randomized clinical trials.

Wretlind et al. 2023Lipids in health and diseasecited by 15

PMID 37752566PMC10521385DOI 10.1186/s12944-023-01922-zPUB-37752566

CC BY
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Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedIversen 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. PMID 38449081

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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 2. Male or female patients \>18 years with type 2 diabetes (WHO criteria). 3. HbA1c ≥ 48 mmol/mol (6.5 %) 4. eGFR ≥ 30 ml/min/1.73 m2 (estimated by MDRD formula) 5. 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 6. Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion) 7. 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) 8. Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening. 9. Patients must be on stable glucose lowering medication for at least two weeks before the first visit. 10. Must be able to communicate with the investigator. Exclusion Criteria: 1. SBP \> 180 mm Hg at screening 2. Type 1 diabetes mellitus 3. Chronic pancreatitis / previous acute pancreatitis 4. Known or suspected hypersensitivity to trial product(s) or related products. 5. 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 6. 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 7. Inflammatory bowel disease 8. 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 9. Previous bowel resection 10. Body mass index \<18.5 kg/m2 11. Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods 12. Clinical signs of diabetic gastroparesis 13. Impaired liver function (transaminases \> two times upper reference levels) 14. The receipt of any investigational product 90 days prior to this trial 15. Known or suspected abuse of alcohol or narcotics 16. Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

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