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LiRA2

WithdrawnPhase 2

The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease

Lead sponsor

Bo Feldt-Rasmussen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Chronic kidney disease, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoint

•Postprandial glucose

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 IDNCT02284230

Org study IDU1111-1149-7801

Timeline

Milestones

Study first posted2014-11-05estimated

Last update posted2015-08-24estimated

Study start2014-12 (month precision)

Primary completion2015-08actual (month precision)

Study completion2015-08actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Chronic kidney diseasePrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•End-stage renal disease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)

•Impaired glucose tolerance (2h plasma glucose ≥ 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l) evaluated at the screening visit

Exclusion criteria

•Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)

•Chronic pancreatitis / previous acute pancreatitis

•Known or suspected hypersensitivity to trial product(s) or related products

•Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy 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, which in the investigator's opinion could interfere with the results of the trial

•Clinical suspicion of cardiac disease currently investigated

•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

•Body mass index (BMI) <20 kg/m2 and/or >50 kg/m2

•Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*

•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

•Screening calcitonin ≥ 50 ng/l

•Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.

* Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.

Endpoints (17)

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

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Weight

Time frame:The trial visit of week 26

descriptive

Secondary/protocol endpoint

Body composition

Time frame:The trial visit of week 26

descriptive, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Plasma glucose during oral glucose tolerance test at week 26

Time frame:The trial visit of week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Fasting values of glucometabolic hormones

Time frame:The trial visit of week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Insulin resistance

Time frame:The trial visit of week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Beta cell function

Time frame:The trial visit of week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in glycemic state

Time frame:The trial visit of week 26

categorical status, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Blood pressure

Time frame:The trial visit of week 26

change from baseline, improvement

Secondary/protocol endpoint

Pulse

Time frame:The trial visit of week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Cardiac autonomic function

Time frame:The trial visit of week 26

change from baseline, improvement

Secondary/protocol endpoint

Arterial stiffness

Time frame:The trial visit of week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Cardiovascular and endothelial risk markers

Time frame:The trial visit of week 26

descriptive, improvement

Secondary/protocol endpoint/low confidence

Prothrombotic state

Time frame:The trial visit of week 26

Fibrinogen, change

change from baseline, improvement

componentsFibrinogen, change

Secondary/protocol endpoint

Lipid profile

Time frame:The trial visit of week 26

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Hypoglycemic incidents

Time frame:From the randomisation to trial visit of week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Plasma liraglutide

Time frame:The trial visit of week 26

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Cardiac function and perfusion

Time frame:The trial visit of week 26

descriptive

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.