DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01394341

CompletedPhase 4

Liraglutide Treatment to Patients With Severe Renal Insufficiency

Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Lead sponsor

Bo Feldt-Rasmussen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

40

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•Plasma concentration (steady state)

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 IDNCT01394341
Org study IDH-3-2011-032
Secondary ID2010-021922-36

Timeline

Milestones

Study first posted2011-07-14estimated
Last update posted2013-10-09estimated
Study start2011-09 (month precision)
Primary completion2013-10actual (month precision)
Study completion2013-10actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•patients with T2D in dialysis
•Male or female; aged 18-85 years
•End-stage renal disease
•Chronic dialysis treatment (minimum 3 months)
•T2D (diagnosed according to WHO criteria)
•Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
•Documented beta cell function (evaluated by a glucagon test)

Inclusion criteria - patients with T2D and normal kidney function

•Male or female; aged 18-85 years
•Normal kidney function: Plasma creatinine <0.105 mmol/L for men and <0.090 mmol/L for women
•T2D (diagnosed according to WHO criteria)
•Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
•Documented beta cell function (evaluated by a glucagon test)
•Hemoglobin A1c ≥6.5%

Exclusion criteria

•both groups
•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 or other drugs, 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 investigators' opinion could interfere with the results of the trial
•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
•Body mass index ≤ 18.5 kg/m2 or ≥ 50.0 kg/m2
•Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
•Clinical signs of diabetic gastroparesis
•Impaired liver function (transaminases >two times upper reference levels)
•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

Endpoints (5)

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

Glycemic / diabetes
2
Safety / tolerability / PK
2
Cardiometabolic biomarkers
1

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Glycaemic control

Time frame:12 weeka

descriptive, improvement

Secondary/protocol endpoint

Pancreatic beta-cell function

Time frame:12 weeks

C-peptide AUC

descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Cardiovascular risk factors (lipids and blood pressure)

Time frame:12 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Plasma liraglutide concentration (pmol/L)

Time frame:12 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Hypoglycaemia; minor or major

Time frame:12 weeks

Documented hypoglycemia

event count, event

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.