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LIRALBU

CompletedPhase 4

Antiproteinuric Effects of Liraglutide Treatment

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

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 ≥30UACR ≥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

NCT IDNCT02545738
Org study ID2014-004502-15

Timeline

Milestones

Study first posted2015-09-10estimated
Last update posted2016-08-10estimated
Study start2015-04 (month precision)
Primary completion2016-05actual (month precision)
Study completion2016-05actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Cardiometabolic biomarkers
4
Renal / kidney
2

Renal / kidney

2 endpoints
Primary/protocol endpoint

Change in albuminuria

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in kidney function

Time frame:24 weeks

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in renin-angiotensin system hormones

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in 24h blood pressure

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in markers of inflammation

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.