GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease

Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Renal Outcomes in Humans With Diabetic Kidney Disease

Lead sponsor

Karl Neff

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•MCP-1:Creatinine Ratio in Urine

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 IDNCT01847313

Org study IDGLP-1-2012-01

Timeline

Milestones

Study first posted2013-05-06estimated

Last update posted2019-02-08actual

Results first posted2019-02-08actual

Study start2013-04 (month precision)

Primary completion2015-11actual (month precision)

Study completion2015-11actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT)

•Male or female aged above 30 years

•Have a negative pregnancy test at screening (women of child bearing potential only)

•Body mass index (BMI) of 25kg/m2 or greater

•On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study

•Established microalbuminuria

•Estimated glomerular filtration rate (eGFR) 30ml/min/1.73m2 or above by Modification of Diet in Renal Disease (MDRD) formula

Exclusion criteria

•Patients with any cognitive impediment that preclude the patient from giving free and informed consent

•Patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment

•Patients with stage 4-5 renal disease, defined as an eGFR of 30ml/min/1.73m2 or less

•Patients who have used a GLP-1 agent in the last 6 months

•Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study

•Previous pancreatitis

•Hypersensitivity to GLP-1 analogues

•Proliferative diabetic retinopathy

•Any other contraindications, as per the SmPC for liraglutide

•Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements

•Concurrent treatment with an investigational drug or participation in another clinical trial

•Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product

Endpoints (12)

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

Safety / tolerability / PK

Other (unclassified)

Cardiometabolic biomarkers

Renal / kidney

7 endpoints

Primary/registry result/low confidence

MCP-1:Creatinine Ratio in Urine

Time frame:Up to 26 weeks

ratio, improvement

Posted result

Group	Value (mean), ng/mmol	95% CI
Liraglutide	27.9	—
Control	24.3	—

Secondary/registry result

Urine Albumin:Creatinine Ratio

Time frame:Up to 26 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/registry result

Urinary Albumin Excretion Rate

Time frame:Up to 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), µg/min	95% CI
Liraglutide	144.1	—
Control	132.4	—

Secondary/registry result/low confidence

sCD163:Creatinine Ratio in Urine

Time frame:Up to 26 weeks

ratio, improvement

Posted result

Group	Value (mean), pg/mmol	95% CI
Liraglutide	27.9	—
Control	24.3	—

Secondary/protocol endpoint

Urine Albumin:Creatinine Ratio

Time frame:Up to 26 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

Urinary Albumin Excretion Rate

Time frame:Up to 26 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

sCD163:Creatinine Ratio in Urine

Time frame:Up to 26 weeks

ratio, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/registry result

sCD163 in Serum

Time frame:Up to 26 weeks

sCD163 serum

change from baseline, improvement

Posted result

Group	Value (mean), ng/ml	95% CI
Liraglutide	82	—
Control	84	—

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Safety in All Participants as Measured by Adverse Event Rate

Time frame:Up to 34 weeks

Treatment-emergent AEs (any)

event count, event

Other_pre_specified/registry result

Safety in All Participants as Measured by Adverse Event Rate

Time frame:Up to 34 weeks

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

MCP-1:Creatinine Ratio in Urine

Time frame:Up to 26 weeks

ratio, descriptive

Secondary/protocol endpoint/low confidence

sCD163 in Serum

Time frame:Up to 26 weeks

concentration, descriptive

Publications (25)

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Glucagon-like peptide-1 analogue therapy for psoriasis patients with obesity and type 2 diabetes: a prospective cohort study.
Journal of the European Academy of Dermatology and Venereology : JEADV2013 Nov (month)PMID22691169doi:10.1111/j.1468-3083.2012.04609.xvia CT.gov background
Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study.
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2013 Jul-Aug (year)PMID22608055doi:10.1016/j.soard.2012.03.009via CT.gov background
Bariatric surgery does not exacerbate and may be beneficial for the microvascular complications of type 2 diabetes.
Diabetes care2012 Dec (month)PMID23173142doi:10.2337/dc11-2353via CT.gov background
Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).
Diabetes care2012 Jun (month)PMID22517736doi:10.2337/dc12-0413via CT.gov background
Inflammation in diabetic nephropathy.
Mediators of inflammation2012 (year)PMID22969168doi:10.1155/2012/146154via CT.gov background
Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis.
Diabetologia2011 Nov (month)PMID21744074doi:10.1007/s00125-011-2232-3via CT.gov background
Glucagon-like peptide analogues for type 2 diabetes mellitus.
The Cochrane database of systematic reviews2011 Oct 5PMID21975753doi:10.1002/14651858.CD006423.pub2via CT.gov background
Inflammatory molecules and pathways in the pathogenesis of diabetic nephropathy.
Nature reviews. Nephrology2011 Jun (month)PMID21537349doi:10.1038/nrneph.2011.51via CT.gov background
Glucagon-like peptide-1 receptor agonist ameliorates renal injury through its anti-inflammatory action without lowering blood glucose level in a rat model of type 1 diabetes.
Diabetologia2011 Apr (month)PMID21253697doi:10.1007/s00125-010-2028-xvia CT.gov background
Sitagliptin reduces albuminuria in patients with type 2 diabetes.
Endocrine journal2011 (year)PMID21206136doi:10.1507/endocrj.k10e-382via CT.gov background
Chronic administration of the glucagon-like peptide-1 analog, liraglutide, delays the onset of diabetes and lowers triglycerides in UCD-T2DM rats.
Diabetes2010 Oct (month)PMID20622169doi:10.2337/db09-1564via CT.gov background
Selecting GLP-1 agonists in the management of type 2 diabetes: differential pharmacology and therapeutic benefits of liraglutide and exenatide.
Therapeutics and clinical risk management2010 Sep 7PMID20856686doi:10.2147/tcrm.s7313via CT.gov background
Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide.
British journal of clinical pharmacology2009 Dec (month)PMID20002084doi:10.1111/j.1365-2125.2009.03536.xvia CT.gov background
Effect of the monocyte chemoattractant protein-1/CC chemokine receptor 2 system on nephrin expression in streptozotocin-treated mice and human cultured podocytes.
Diabetes2009 Sep (month)PMID19587356doi:10.2337/db08-0895via CT.gov background
Invariant NKT cells and CD1d(+) cells amass in human omentum and are depleted in patients with cancer and obesity.
European journal of immunology2009 Jul (month)PMID19585513doi:10.1002/eji.200939349via CT.gov background
Are natural killer cells protecting the metabolically healthy obese patient?
Obesity (Silver Spring, Md.)2009 Mar (month)PMID19238145doi:10.1038/oby.2008.565via CT.gov background
Anti-proliferative effect of pro-inflammatory cytokines in cultured beta cells is associated with extracellular signal-regulated kinase 1/2 pathway inhibition: protective role of glucagon-like peptide -1.
Journal of molecular endocrinology2008 Jul (month)PMID18487229doi:10.1677/JME-07-0154via CT.gov background
Inhibition of MCP-1/CCR2 pathway ameliorates the development of diabetic nephropathy.
Biochemical and biophysical research communications2007 Sep 7PMID17631861doi:10.1016/j.bbrc.2007.06.148via CT.gov background
Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration.
American journal of nephrology2006 (year)PMID17167242doi:10.1159/000098004via CT.gov background
Monocyte chemoattractant protein-1 promotes the development of diabetic renal injury in streptozotocin-treated mice.
Kidney international2006 Jan (month)PMID16374426doi:10.1038/sj.ki.5000014via CT.gov background
Erythromycin ameliorates renal injury via anti-inflammatory effects in experimental diabetic rats.
Diabetologia2005 Nov (month)PMID16231067doi:10.1007/s00125-005-1945-6via CT.gov background
Methotrexate prevents renal injury in experimental diabetic rats via anti-inflammatory actions.
Journal of the American Society of Nephrology : JASN2005 Nov (month)PMID16177002doi:10.1681/ASN.2004111011via CT.gov background
Chronic kidney disease: the global challenge.
Lancet (London, England)2005 Jan 22-28 (month)PMID15664230doi:10.1016/S0140-6736(05)17789-7via CT.gov background
Macrophages in mouse type 2 diabetic nephropathy: correlation with diabetic state and progressive renal injury.
Kidney international2004 Jan (month)PMID14675042doi:10.1111/j.1523-1755.2004.00367.xvia CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.