Diabetic Kidney DiseasePhase 3NCT01847313

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

A Phase 3 study testing Liraglutide in people with Diabetic Kidney Disease, run by Karl Neff at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Diabetic Kidney Disease
What is being tested?: Liraglutide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteIreland
Study dates: Apr 2013to Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Ireland1 site

St Vincent's Healthcare Group
Dublin, Dublin 4

Other trials in Ireland

About this study

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

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.

Read the detailed description

A randomised controlled trial for patients with microalbuminuria and type 2 diabetes. Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6 months.

Conditions: Diabetic Kidney Disease
Being tested: Liraglutide
Keywords: kidney, diabetes, glp-1
Medical subject headings: Diabetic Nephropathies, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LiraglutideDrug
Also called Glucagon like peptide 1 receptor agonist, NN2211
Daily administration of liraglutide for 6 months

Study groups in NCT01847313
Study group	Role	What they receive
Liraglutide	Active comparator	Liraglutide 0.6 mg daily Receives: Drug: Liraglutide
Control	No intervention	Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

MCP-1:Creatinine Ratio in Urine
Spot urine sample for MCP-1 and creatinine
Measured: Up to 26 weeks

Secondary outcomes (4)

Urine Albumin:Creatinine Ratio
Spot urine sample for albumin and creatinine
Measured: Up to 26 weeks
Urinary Albumin Excretion Rate
Albuminuria as Measured by 24 Hour Albumin Excretion Rate
Measured: Up to 26 weeks
sCD163 in Serum
Serum sample for sCD163
Measured: Up to 26 weeks
sCD163:Creatinine Ratio in Urine
Spot urine sample for MCP-1 and creatinine
Measured: Up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Nov 2015

First posted6 May 2013 (estimated)
Study startApr 2013
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847313
Sponsor's protocol ID: GLP-1-2012-01
Status last verified: Sep 2018
First submitted: 29 Apr 2013
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fenske WK, Dubb S, Bueter M, Seyfried F, Patel K, Tam FW, Frankel AH, le Roux CW. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study. Surg Obes Relat Dis. 2013 Jul-Aug;9(4):559-68. doi: 10.1016/j.soard.2012.03.009. Epub 2012 Apr 10.
PubMed 22608055
Miras AD, Chuah LL, Lascaratos G, Faruq S, Mohite AA, Shah PR, Gill M, Jackson SN, Johnston DG, Olbers T, le Roux CW. Bariatric surgery does not exacerbate and may be beneficial for the microvascular complications of type 2 diabetes. Diabetes Care. 2012 Dec;35(12):e81. doi: 10.2337/dc11-2353. No abstract available.
PubMed 23173142
Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
PubMed 15664230
Navarro-Gonzalez JF, Mora-Fernandez C, Muros de Fuentes M, Garcia-Perez J. Inflammatory molecules and pathways in the pathogenesis of diabetic nephropathy. Nat Rev Nephrol. 2011 Jun;7(6):327-40. doi: 10.1038/nrneph.2011.51. Epub 2011 May 3.
PubMed 21537349
Lim AK, Tesch GH. Inflammation in diabetic nephropathy. Mediators Inflamm. 2012;2012:146154. doi: 10.1155/2012/146154. Epub 2012 Aug 21.
PubMed 22969168
Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD006423. doi: 10.1002/14651858.CD006423.pub2.
PubMed 21975753
Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
PubMed 21744074
Lynch LA, O'Connell JM, Kwasnik AK, Cawood TJ, O'Farrelly C, O'Shea DB. Are natural killer cells protecting the metabolically healthy obese patient? Obesity (Silver Spring). 2009 Mar;17(3):601-5. doi: 10.1038/oby.2008.565. Epub 2008 Dec 18.
PubMed 19238145
Lynch L, O'Shea D, Winter DC, Geoghegan J, Doherty DG, O'Farrelly C. Invariant NKT cells and CD1d(+) cells amass in human omentum and are depleted in patients with cancer and obesity. Eur J Immunol. 2009 Jul;39(7):1893-901. doi: 10.1002/eji.200939349.
PubMed 19585513
Chow FY, Nikolic-Paterson DJ, Ozols E, Atkins RC, Rollin BJ, Tesch GH. Monocyte chemoattractant protein-1 promotes the development of diabetic renal injury in streptozotocin-treated mice. Kidney Int. 2006 Jan;69(1):73-80. doi: 10.1038/sj.ki.5000014.
PubMed 16374426
Chow F, Ozols E, Nikolic-Paterson DJ, Atkins RC, Tesch GH. Macrophages in mouse type 2 diabetic nephropathy: correlation with diabetic state and progressive renal injury. Kidney Int. 2004 Jan;65(1):116-28. doi: 10.1111/j.1523-1755.2004.00367.x.
PubMed 14675042
Kanamori H, Matsubara T, Mima A, Sumi E, Nagai K, Takahashi T, Abe H, Iehara N, Fukatsu A, Okamoto H, Kita T, Doi T, Arai H. Inhibition of MCP-1/CCR2 pathway ameliorates the development of diabetic nephropathy. Biochem Biophys Res Commun. 2007 Sep 7;360(4):772-7. doi: 10.1016/j.bbrc.2007.06.148. Epub 2007 Jul 6.
PubMed 17631861
Tarabra E, Giunti S, Barutta F, Salvidio G, Burt D, Deferrari G, Gambino R, Vergola D, Pinach S, Perin PC, Camussi G, Gruden G. Effect of the monocyte chemoattractant protein-1/CC chemokine receptor 2 system on nephrin expression in streptozotocin-treated mice and human cultured podocytes. Diabetes. 2009 Sep;58(9):2109-18. doi: 10.2337/db08-0895. Epub 2009 Jul 8.
PubMed 19587356
Navarro JF, Milena FJ, Mora C, Leon C, Garcia J. Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration. Am J Nephrol. 2006;26(6):562-70. doi: 10.1159/000098004. Epub 2006 Dec 13.
PubMed 17167242
Yozai K, Shikata K, Sasaki M, Tone A, Ohga S, Usui H, Okada S, Wada J, Nagase R, Ogawa D, Shikata Y, Makino H. Methotrexate prevents renal injury in experimental diabetic rats via anti-inflammatory actions. J Am Soc Nephrol. 2005 Nov;16(11):3326-38. doi: 10.1681/ASN.2004111011. Epub 2005 Sep 21.
PubMed 16177002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Renal Outcomes in Humans With Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT01847313
Acronym / sponsor ID: GLP-1-2012-01
Conditions: Diabetic Kidney Disease
Keywords: kidney, diabetes, glp-1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Karl NeffUniversity, hospital or other
Collaborators: University College Dublin
Study start: Apr 2013
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 6 May 2013 (estimated)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A randomised controlled trial for patients with microalbuminuria and type 2 diabetes. Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Liraglutide	Active comparator	Drug: LiraglutideLiraglutide 0.6 mg daily
Control	No intervention	–Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LiraglutideAlso: Glucagon like peptide 1 receptor agonist, NN2211Daily administration of liraglutide for 6 months	Drug	Liraglutide

Primary outcome

MCP-1:Creatinine Ratio in Urine
Time frame: Up to 26 weeks
Spot urine sample for MCP-1 and creatinine

4 secondary outcomes

Urine Albumin:Creatinine Ratio
Time frame: Up to 26 weeks
Urinary Albumin Excretion Rate
Time frame: Up to 26 weeks
sCD163 in Serum
Time frame: Up to 26 weeks
sCD163:Creatinine Ratio in Urine
Time frame: Up to 26 weeks

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide	10	10
Control	10	8

Primary outcome: MCP-1:Creatinine Ratio in Urine

Time frame: Up to 26 weeks. Mean (Standard Deviation). Unit: ng/mmol

Measure	Liraglutide n = 9	Control n = 8
Value	27.9 (14.3)	24.3 (15.4)

Population analysed: Liraglutide group contained an analytical outlier which was excluded from further analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Starting from the first administration of the IMP through to the End of Study Visit (30 weeks) all Adverse Event and Serious Adverse event information was collected at each visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide	1 of 10 (10%)	8 of 10 (80%)	0 of 10
Control	1 of 10 (10%)	7 of 10 (70%)	1 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22608055Fenske WK, Dubb S, Bueter M, Seyfried F, Patel K, Tam FW, Frankel AH, le Roux CW. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study. Surg Obes Relat Dis. 2013 Jul-Aug;9(4):559-68. doi: 10.1016/j.soard.2012.03.009. Epub 2012 Apr 10.
Background: PubMed 23173142Miras AD, Chuah LL, Lascaratos G, Faruq S, Mohite AA, Shah PR, Gill M, Jackson SN, Johnston DG, Olbers T, le Roux CW. Bariatric surgery does not exacerbate and may be beneficial for the microvascular complications of type 2 diabetes. Diabetes Care. 2012 Dec;35(12):e81. doi: 10.2337/dc11-2353. No abstract available.
Background: PubMed 15664230Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
Background: PubMed 21537349Navarro-Gonzalez JF, Mora-Fernandez C, Muros de Fuentes M, Garcia-Perez J. Inflammatory molecules and pathways in the pathogenesis of diabetic nephropathy. Nat Rev Nephrol. 2011 Jun;7(6):327-40. doi: 10.1038/nrneph.2011.51. Epub 2011 May 3.
Background: PubMed 22969168Lim AK, Tesch GH. Inflammation in diabetic nephropathy. Mediators Inflamm. 2012;2012:146154. doi: 10.1155/2012/146154. Epub 2012 Aug 21.
Background: PubMed 21975753Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD006423. doi: 10.1002/14651858.CD006423.pub2.
Background: PubMed 21744074Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
Background: PubMed 19238145Lynch LA, O'Connell JM, Kwasnik AK, Cawood TJ, O'Farrelly C, O'Shea DB. Are natural killer cells protecting the metabolically healthy obese patient? Obesity (Silver Spring). 2009 Mar;17(3):601-5. doi: 10.1038/oby.2008.565. Epub 2008 Dec 18.
Background: PubMed 19585513Lynch L, O'Shea D, Winter DC, Geoghegan J, Doherty DG, O'Farrelly C. Invariant NKT cells and CD1d(+) cells amass in human omentum and are depleted in patients with cancer and obesity. Eur J Immunol. 2009 Jul;39(7):1893-901. doi: 10.1002/eji.200939349.
Background: PubMed 16374426Chow FY, Nikolic-Paterson DJ, Ozols E, Atkins RC, Rollin BJ, Tesch GH. Monocyte chemoattractant protein-1 promotes the development of diabetic renal injury in streptozotocin-treated mice. Kidney Int. 2006 Jan;69(1):73-80. doi: 10.1038/sj.ki.5000014.
Background: PubMed 14675042Chow F, Ozols E, Nikolic-Paterson DJ, Atkins RC, Tesch GH. Macrophages in mouse type 2 diabetic nephropathy: correlation with diabetic state and progressive renal injury. Kidney Int. 2004 Jan;65(1):116-28. doi: 10.1111/j.1523-1755.2004.00367.x.
Background: PubMed 17631861Kanamori H, Matsubara T, Mima A, Sumi E, Nagai K, Takahashi T, Abe H, Iehara N, Fukatsu A, Okamoto H, Kita T, Doi T, Arai H. Inhibition of MCP-1/CCR2 pathway ameliorates the development of diabetic nephropathy. Biochem Biophys Res Commun. 2007 Sep 7;360(4):772-7. doi: 10.1016/j.bbrc.2007.06.148. Epub 2007 Jul 6.

Related trials for Diabetic Kidney Disease

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Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
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Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carel le Roux, MBBS PhD study director

University College Dublin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide in people with Diabetic Kidney Disease, run by Karl Neff at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCP-1:Creatinine Ratio in Urine (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847313, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.