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LIRALBU
CompletedPhase 4Antiproteinuric Effects of Liraglutide Treatment
Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
32
actual
Study population
Chronic kidney disease, Type 2 diabetes
Key I/E criteria
•eGFR ≥30•UACR ≥30
Primary endpoint
•Albuminuria
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Renal / kidney
2 endpointsChange in albuminuria
Time frame:24 weeks
change from baseline, improvement
Change in kidney function
Time frame:24 weeks
eGFR, change
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsChange in renin-angiotensin system hormones
Time frame:24 weeks
change from baseline, improvement
Change in 24h blood pressure
Time frame:24 weeks
change from baseline, improvement
Change in markers of inflammation
Time frame:24 weeks
change from baseline, improvement
24h heart rate
Time frame:24 weeks
Heart rate, change
change from baseline, improvement
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
- Lipids in health and disease2023 Sep 26PMID37752566doi:10.1186/s12944-023-01922-zvia clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2017 Feb (month)PMID27753201doi:10.1111/dom.12808via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.