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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01847313 (opens ClinicalTrials.gov in a new tab)Other idGLP-1-2012-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
20 participants (actual)
Sponsor
Karl Neff · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Ireland

Start
Apr 2013
Primary completion
Nov 2015
Completion
Nov 2015
First posted
6 May 2013 (estimated)
Last update posted
8 Feb 2019
Conditions
Diabetic Kidney Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

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

    NCT01847313

    Apr 2013 to Nov 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst form, can lead to early cardiovascular death or kidney failure. A group of medicines used to treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory by studying the effect of GLP-1 on kidney function in people with diabetes. To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1 treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney function using blood and urine tests. The investigators will compare these results to patients with DKD who do not receive GLP-1 treatment. If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then it could be developed as a viable new treatment for people with DKD, and may significantly reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major advance in the treatment of DKD.

Interventions

  • LiraglutideDrug

Arms2

  • Active comparator

    Liraglutide

    Liraglutide 0.6 mg daily

  • No intervention

    Control

    Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. MCP-1:Creatinine Ratio in Urine

    Time frame · Up to 26 weeks

    Registry description

    Spot urine sample for MCP-1 and creatinine

Secondary outcomes(4)

  1. Urine Albumin:Creatinine Ratio

    Time frame · Up to 26 weeks

    Registry description

    Spot urine sample for albumin and creatinine

  2. Urinary Albumin Excretion Rate

    Time frame · Up to 26 weeks

    Registry description

    Albuminuria as Measured by 24 Hour Albumin Excretion Rate

  3. sCD163 in Serum

    Time frame · Up to 26 weeks

    Registry description

    Serum sample for sCD163

  4. sCD163:Creatinine Ratio in Urine

    Time frame · Up to 26 weeks

    Registry description

    Spot urine sample for MCP-1 and creatinine

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 26 weeks

MCP-1:Creatinine Ratio in Urine

GroupValue (ng/mmol)Spread
Liraglutide27.914.3
Control24.315.4
Secondary and other outcome results(5)
Secondary outcome· Up to 26 weeks

Urine Albumin:Creatinine Ratio

GroupValue
Secondary outcomeMean· Up to 26 weeks

Urinary Albumin Excretion Rate

GroupValue (µg/min)Spread
Liraglutide144.1232.6
Control132.4101.3
Secondary outcomeMean· Up to 26 weeks

sCD163 in Serum

GroupValue (ng/ml)Spread
Liraglutide8234
Control8423
Secondary outcomeMean· Up to 26 weeks

sCD163:Creatinine Ratio in Urine

GroupValue (pg/mmol)Spread
Liraglutide27.914.0
Control24.315.4
Other pre specified outcome· Up to 34 weeks

Safety in All Participants as Measured by Adverse Event Rate

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideLiraglutide 0.6 mg daily administration for 6 months0 / 101 / 108 / 10
ControlStandard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist1 / 101 / 107 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Meta-analysis (pooled) · 2011

11 results

Glucagon-like peptide analogues for type 2 diabetes mellitus.

Shyangdan et al. 2011The Cochrane database of systematic reviewscited by 126

PMID 21975753PMC6486297DOI 10.1002/14651858.cd006423.pub2PUB-21975753

Rights unknown11 results
Source linkSee results (11)

Indexing hint: Clinical trial · 2009

6 results

Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide.

Jacobsen et al. 2009British journal of clinical pharmacologycited by 144

PMID 20002084PMC2810801DOI 10.1111/j.1365-2125.2009.03536.xPUB-20002084

Rights unknown6 results
Source linkSee results (6)

More studies

4 studies on this page

PubMed tag: none · 2013

Glucagon-like peptide-1 analogue therapy for psoriasis patients with obesity and type 2 diabetes: a prospective cohort study.

Ahern et al. 2013Journal of the European Academy of Dermatology and Venereology : JEADVcited by 62

PMID 22691169DOI 10.1111/j.1468-3083.2012.04609.xPUB-22691169

Full text at the publisher
Publisher page

PubMed tag: none · 2011

Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis.

Hogan et al. 2011Diabetologiacited by 149

PMID 21744074PMC3188710DOI 10.1007/s00125-011-2232-3PUB-21744074

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2010

Chronic administration of the glucagon-like peptide-1 analog, liraglutide, delays the onset of diabetes and lowers triglycerides in UCD-T2DM rats.

Cummings et al. 2010Diabetescited by 59

PMID 20622169PMC3279561DOI 10.2337/db09-1564PUB-20622169

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Review · 2010

Selecting GLP-1 agonists in the management of type 2 diabetes: differential pharmacology and therapeutic benefits of liraglutide and exenatide.

Pinkney et al. 2010Therapeutics and clinical risk managementcited by 22

PMID 20856686PMC2940748DOI 10.2147/tcrm.s7313PUB-20856686

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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